Trial Outcomes & Findings for Fibrin Sealant Vascular Surgery Study (NCT NCT00576420)

NCT ID: NCT00576420

Last Updated: 2012-11-27

Results Overview

Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 101 participants
• Primary outcome timeframe: 4 minutes post start of treatment application
• Results posted on: 2012-11-27

Participant Flow

Participants were enrolled at 12 clinical sites in the United States, beginning December 2007. The last participant completed the study in December 2008

101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.

Participant milestones

Measure	FS VH S/D 500 S-apr - 60 Seconds Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time	FS VH S/D 500 S-apr - 120 Seconds FS VH S/D 500 s-apr, 120 - seconds polymerization time	Control Group Manual compression with surgical gauze pads.
Overall Study STARTED	26	24	23
Overall Study COMPLETED	26	24	22
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	FS VH S/D 500 S-apr - 60 Seconds Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time	FS VH S/D 500 S-apr - 120 Seconds FS VH S/D 500 s-apr, 120 - seconds polymerization time	Control Group Manual compression with surgical gauze pads.
Overall Study Death	0	0	1

Baseline Characteristics

Fibrin Sealant Vascular Surgery Study

Baseline characteristics by cohort

Measure	FS VH S/D 500 S-apr - 60 Seconds n=26 Participants FS VH S/D 500 s-apr, 60 - seconds polymerization time	FS VH S/D 500 S-apr - 120 Seconds n=24 Participants FS VH S/D 500 s-apr, 120 - seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Total n=73 Participants Total of all reporting groups
Age Continuous	63.0 years FULL_RANGE 12.7 • n=5 Participants	67.0 years FULL_RANGE 14.6 • n=7 Participants	63.0 years FULL_RANGE 14.4 • n=5 Participants	63 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	24 participants n=7 Participants	23 participants n=5 Participants	73 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

Hemostasis at the study suture line must be maintained.

Participants were considered treatment failures if they met any of the following conditions:

• Did not achieve hemostasis at 4 minutes
• Required additional hemostatic treatment during the first 4 minutes of the observation period
• Experienced rebleeding after the first 4 minutes of the observation period.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. Primary Hemostasis Achieved at 4 Minutes	46.2 percentage of participants	62.5 percentage of participants	34.8 percentage of participants	—	—	—	—	—	—	—	—	—
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. Additional Treatment Required for Hemostasis	30.8 percentage of participants	25.0 percentage of participants	52.2 percentage of participants	—	—	—	—	—	—	—	—	—
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. Intraoperative Rebleeding After Primary Hemostasis	3.8 percentage of participants	0.0 percentage of participants	4.3 percentage of participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Participants were considered treatment failures if they met any of the following conditions:

• Did not achieve hemostasis at 4 minutes
• Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period
• Experienced rebleeding after the first 4 minutes of the observation period.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line	46.2 percentage of participants Interval 30.1 to 62.2	62.5 percentage of participants Interval 46.2 to 78.8	34.8 percentage of participants Interval 18.4 to 51.1	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

Investigators were shown videos of bleeding severities to standardize assessments.

1. Moderate bleeding defined as:

• Either >25% of the suture line bleeds, or
• ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or
• 1 pulsatile suture line bleeding was present.

2. Severe bleeding defined as:

• Either >50% of the suture line bleeds, or
• ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
• >1 pulsatile suture line bleeding was present, or
• ≥1 spurting suture line bleeding was present.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=14 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=12 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=13 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	50.0 percentage of participants Interval 28.0 to 72.0	66.7 percentage of participants Interval 44.3 to 89.1	38.5 percentage of participants Interval 16.3 to 60.7	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 minutes post start of treatment application

Population: Intent to Treat

Investigators were shown videos of bleeding severities to standardize assessments.

Severe bleeding defined as:

• Either >50% of the suture line bleeds, or
• ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
• >1 pulsatile suture line bleeding was present, or
• ≥1 spurting suture line bleeding was present.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=12 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=12 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=10 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding	41.7 percentage of participants Interval 18.3 to 65.1	58.3 percentage of participants Interval 34.9 to 81.7	30.0 percentage of participants Interval 6.2 to 53.8	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 minutes post start of treatment application start

Population: Intent to Treat

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants Achieving Hemostasis at 6 Minutes	61.5 percentage of participants Interval 45.8 to 77.2	75.0 percentage of participants Interval 60.5 to 89.5	34.8 percentage of participants Interval 18.4 to 51.1	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 10 minutes post start of treatment application

Population: Intent to Treat

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants Achieving Hemostasis at 10 Minutes	65.4 percentage of participants Interval 50.0 to 80.7	75.0 percentage of participants Interval 60.5 to 89.5	43.5 percentage of participants Interval 26.5 to 60.5	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Intraoperative day 0

Population: Intent to Treat

Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line	3.8 percentage of participants Interval 0.0 to 10.0	0.0 percentage of participants Interval 0.0 to 0.0	4.3 percentage of participants Interval 0.0 to 11.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Postoperative through day 30 ± 5

Population: Intent to Treat

Any rebleeding requiring surgical reexploration

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Intraoperative (day 0) through day 30 ± 5

Population: Intent to Treat

Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=23 Participants Manual compression with surgical gauze pads.	Control Group Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants With Any Transfusion Requirement	3.8 percentage of participants Interval 0.0 to 10.0	12.5 percentage of participants Interval 1.4 to 23.6	13.0 percentage of participants Interval 1.5 to 24.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (procedure day) through day 30 ± 5

Population: Safety Analysis Set

Determined clinically and defined as absence of blood flow through the graft.

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants With Graft Occlusions	7.7 percentage of participants Interval 0.0 to 16.3	4.2 percentage of participants Interval 0.0 to 10.9	6.0 percentage of participants Interval 0.5 to 11.5	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (procedure day) through day 30 ± 5

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percentage of Participants With Infections at the Surgical Site	3.8 percentage of participants Interval 0.0 to 10.0	8.3 percentage of participants Interval 0.0 to 17.6	6.0 percentage of participants Interval 0.5 to 11.5	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline Systolic blood pressure	137.5 mm Hg Interval 95.0 to 182.0	142.5 mm Hg Interval 96.0 to 208.0	141.5 mm Hg Interval 95.0 to 208.0	150.0 mm Hg Interval 91.0 to 194.0	—	—	—	—	—	—	—	—
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline Diastolic blood pressure	71.0 mm Hg Interval 46.0 to 100.0	73.5 mm Hg Interval 54.0 to 137.0	72.0 mm Hg Interval 46.0 to 137.0	78.0 mm Hg Interval 48.0 to 111.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=50 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 n=25 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 n=47 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 n=20 Participants Manual compression with surgical gauze pads
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure Systolic blood pressure	-10.1 percent change Interval -36.8 to 21.4	-6.5 percent change Interval -42.2 to 44.4	-9.8 percent change Interval -42.2 to 44.4	-17.2 percent change Interval -51.5 to 15.4	-6.4 percent change Interval -34.7 to 54.1	-12.4 percent change Interval -47.1 to 62.5	-7.9 percent change Interval -47.1 to 62.5	-11.0 percent change Interval -29.5 to 44.4	-3.8 percent change Interval -29.7 to 46.9	-3.7 percent change Interval -47.1 to 50.9	-3.8 percent change Interval -47.1 to 50.9	-6.6 percent change Interval -33.5 to 10.0
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure Diastolic blood pressure	-8.2 percent change Interval -66.7 to 100.0	-16.4 percent change Interval -64.6 to 36.5	-11.4 percent change Interval -66.7 to 100.0	-21.9 percent change Interval -45.0 to 41.7	-1.5 percent change Interval -38.5 to 63.0	-19.4 percent change Interval -60.6 to 40.0	-7.5 percent change Interval -60.6 to 63.0	-9.6 percent change Interval -39.4 to 13.8	0.0 percent change Interval -28.6 to 36.7	-7.5 percent change Interval -48.9 to 51.9	-1.1 percent change Interval -48.9 to 51.9	-7.1 percent change Interval -37.5 to 39.4

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Vital Signs: Heart Rate - Preoperative Baseline	72.0 Heart beats/ minute Interval 50.0 to 139.0	71.5 Heart beats/ minute Interval 53.0 to 98.0	72.0 Heart beats/ minute Interval 50.0 to 139.0	74.0 Heart beats/ minute Interval 57.0 to 112.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=50 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=50 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 n=25 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 n=47 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 n=20 Participants Manual compression with surgical gauze pads
Percent Change in Vital Signs: Heart Rate	-7.0 percent change Interval -58.3 to 38.6	-2.6 percent change Interval -35.6 to 37.1	-6.3 percent change Interval -58.3 to 38.6	-9.5 percent change Interval -30.8 to 21.2	-6.7 percent change Interval -34.0 to 27.1	2.0 percent change Interval -30.6 to 32.7	-1.4 percent change Interval -34.0 to 32.7	9.9 percent change Interval -24.4 to 54.5	3.0 percent change Interval -19.5 to 30.6	7.4 percent change Interval -30.1 to 22.9	4.4 percent change Interval -30.1 to 30.6	1.8 percent change Interval -26.8 to 26.3

SECONDARY outcome

Timeframe: Within 14 days prior to date of surgery

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=26 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=23 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=49 Participants Manual compression with surgical gauze pads.	Control Group n=23 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Vital Signs: Respiratory Rate - Preoperative Baseline	18.0 Breaths/ minute Interval 15.0 to 24.0	20.0 Breaths/ minute Interval 13.0 to 20.0	18.0 Breaths/ minute Interval 13.0 to 24.0	18.0 Breaths/ minute Interval 16.0 to 26.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=25 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=47 Participants Manual compression with surgical gauze pads.	Control Group n=21 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=24 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=19 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=43 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Percent Change in Vital Signs: Respiratory Rate	0.0 percent change Interval -35.0 to 33.3	-10.0 percent change Interval -30.0 to 28.6	-10.0 percent change Interval -35.0 to 33.3	0.0 percent change Interval -23.1 to 25.0	0.0 percent change Interval -20.0 to 25.0	0.0 percent change Interval -29.4 to 38.5	0.0 percent change Interval -29.4 to 38.5	0.0 percent change Interval -46.2 to 33.3	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=24 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=46 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=20 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=46 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Hemoglobin	12.00 g/dl Interval 6.6 to 16.5	12.55 g/dl Interval 9.0 to 16.6	12.25 g/dl Interval 6.6 to 16.6	12.15 g/dl Interval 10.1 to 14.7	11.15 g/dl Interval 7.6 to 16.1	12.40 g/dl Interval 8.3 to 14.4	12.05 g/dl Interval 7.6 to 16.1	11.70 g/dl Interval 8.5 to 13.6	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=24 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=46 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=20 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=46 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Hematocrit	37.00 percentage of red blood cells in blood Interval 23.0 to 47.0	37.00 percentage of red blood cells in blood Interval 30.0 to 51.0	37.00 percentage of red blood cells in blood Interval 23.0 to 51.0	39.00 percentage of red blood cells in blood Interval 30.0 to 45.0	35.00 percentage of red blood cells in blood Interval 26.0 to 48.0	38.00 percentage of red blood cells in blood Interval 28.0 to 47.0	37.00 percentage of red blood cells in blood Interval 26.0 to 48.0	36.50 percentage of red blood cells in blood Interval 27.0 to 41.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=24 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=46 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=20 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=46 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Erythrocytes	4.10 x10^6/µl Interval 3.1 to 5.3	4.15 x10^6/µl Interval 3.1 to 5.3	4.10 x10^6/µl Interval 3.1 to 5.3	4.40 x10^6/µl Interval 3.3 to 5.0	3.75 x10^6/µl Interval 2.9 to 5.4	4.15 x10^6/µl Interval 2.8 to 5.8	3.90 x10^6/µl Interval 2.8 to 5.8	4.00 x10^6/µl Interval 2.9 to 4.7	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=24 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=46 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=20 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=46 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Leukocytes	6.31 x10^3/µl Interval 2.48 to 16.22	7.14 x10^3/µl Interval 3.45 to 15.16	6.62 x10^3/µl Interval 2.48 to 16.22	7.98 x10^3/µl Interval 3.62 to 13.76	6.58 x10^3/µl Interval 3.34 to 14.12	7.87 x10^3/µl Interval 4.36 to 16.89	7.00 x10^3/µl Interval 3.34 to 16.89	8.13 x10^3/µl Interval 6.25 to 18.62	—	—	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Basophils	0.05 x10^3/µl Interval 0.0 to 0.12	0.05 x10^3/µl Interval 0.0 to 0.1	0.05 x10^3/µl Interval 0.0 to 0.12	0.04 x10^3/µl Interval 0.0 to 0.1	0.04 x10^3/µl Interval 0.0 to 0.19	0.05 x10^3/µl Interval 0.02 to 0.23	0.05 x10^3/µl Interval 0.0 to 0.23	0.04 x10^3/µl Interval 0.0 to 0.08	—	—	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Eosinophils	0.17 x10^3/µl Interval 0.02 to 0.91	0.14 x10^3/µl Interval 0.02 to 0.96	0.15 x10^3/µl Interval 0.02 to 0.96	0.19 x10^3/µl Interval 0.04 to 0.83	0.21 x10^3/µl Interval 0.02 to 0.96	0.24 x10^3/µl Interval 0.01 to 0.52	0.23 x10^3/µl Interval 0.01 to 0.96	0.21 x10^3/µl Interval 0.08 to 0.46	—	—	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Lymphocytes	1.50 x10^3/µl Interval 0.57 to 3.86	1.74 x10^3/µl Interval 0.56 to 3.1	1.55 x10^3/µl Interval 0.56 to 3.86	1.59 x10^3/µl Interval 1.09 to 4.26	1.50 x10^3/µl Interval 0.6 to 4.59	1.46 x10^3/µl Interval 0.51 to 3.11	1.48 x10^3/µl Interval 0.51 to 4.59	1.94 x10^3/µl Interval 0.86 to 3.82	—	—	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Neutrophils	3.70 x10^3/µl Interval 1.59 to 12.55	4.69 x10^3/µl Interval 2.22 to 13.7	4.11 x10^3/µl Interval 1.59 to 13.7	5.24 x10^3/µl Interval 2.17 to 8.67	4.44 x10^3/µl Interval 2.38 to 9.92	5.23 x10^3/µl Interval 2.72 to 15.38	4.66 x10^3/µl Interval 2.38 to 15.38	5.54 x10^3/µl Interval 3.81 to 14.64	—	—	—	—
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes Monocytes	0.34 x10^3/µl Interval 0.08 to 0.72	0.41 x10^3/µl Interval 0.2 to 0.82	0.36 x10^3/µl Interval 0.08 to 0.82	0.39 x10^3/µl Interval 0.18 to 0.83	0.35 x10^3/µl Interval 0.22 to 0.58	0.43 x10^3/µl Interval 0.22 to 0.77	0.38 x10^3/µl Interval 0.22 to 0.77	0.44 x10^3/µl Interval 0.13 to 0.57	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=23 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=19 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=42 Participants Manual compression with surgical gauze pads.	Control Group n=19 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=25 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=19 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=44 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=16 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Platelets	184.00 x10^3/µl Interval 70.0 to 423.0	204.00 x10^3/µl Interval 56.0 to 442.0	195.50 x10^3/µl Interval 56.0 to 442.0	233.00 x10^3/µl Interval 132.0 to 462.0	226.00 x10^3/µl Interval 138.0 to 538.0	333.00 x10^3/µl Interval 117.0 to 593.0	275.00 x10^3/µl Interval 117.0 to 593.0	295.00 x10^3/µl Interval 199.0 to 386.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=25 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=24 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=49 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=21 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=47 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) Creatinine	4.20 mg/dL Interval 0.5 to 13.8	1.90 mg/dL Interval 0.6 to 13.3	3.50 mg/dL Interval 0.5 to 13.8	2.65 mg/dL Interval 0.5 to 9.4	4.60 mg/dL Interval 0.6 to 12.7	2.40 mg/dL Interval 0.6 to 12.7	3.50 mg/dL Interval 0.6 to 12.7	3.25 mg/dL Interval 0.5 to 11.0	—	—	—	—
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) Bilirubin	0.40 mg/dL Interval 0.2 to 1.0	0.30 mg/dL Interval 0.2 to 1.1	0.30 mg/dL Interval 0.2 to 1.1	0.40 mg/dL Interval 0.2 to 0.7	0.30 mg/dL Interval 0.2 to 3.3	0.40 mg/dL Interval 0.2 to 0.7	0.30 mg/dL Interval 0.2 to 3.3	0.30 mg/dL Interval 0.2 to 0.6	—	—	—	—
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) BUN	24.00 mg/dL Interval 6.0 to 104.0	31.00 mg/dL Interval 8.0 to 122.0	26.00 mg/dL Interval 6.0 to 122.0	29.00 mg/dL Interval 9.0 to 73.0	30.00 mg/dL Interval 4.0 to 72.0	26.00 mg/dL Interval 8.0 to 125.0	27.00 mg/dL Interval 4.0 to 125.0	27.00 mg/dL Interval 6.0 to 84.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=25 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=23 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=48 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=21 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=47 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Alanine Aminotransferase (ALT)	16.00 U/L Interval 4.0 to 47.0	17.00 U/L Interval 7.0 to 43.0	16.00 U/L Interval 4.0 to 47.0	16.50 U/L Interval 7.0 to 29.0	12.00 U/L Interval 4.0 to 32.0	15.00 U/L Interval 4.0 to 39.0	14.00 U/L Interval 4.0 to 39.0	12.00 U/L Interval 4.0 to 20.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=25 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=22 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=47 Participants Manual compression with surgical gauze pads.	Control Group n=19 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=26 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=19 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=45 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Aspartate Aminotransferase (AST)	18.00 U/L Interval 14.0 to 51.0	19.00 U/L Interval 11.0 to 45.0	18.00 U/L Interval 11.0 to 51.0	16.00 U/L Interval 12.0 to 44.0	18.00 U/L Interval 13.0 to 29.0	20.00 U/L Interval 7.0 to 39.0	19.00 U/L Interval 7.0 to 39.0	17.50 U/L Interval 11.0 to 30.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=22 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=21 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=43 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=24 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=18 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=42 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)	25.10 seconds Interval 19.6 to 109.8	26.30 seconds Interval 21.6 to 51.0	25.90 seconds Interval 19.6 to 109.8	25.10 seconds Interval 19.9 to 150.0	24.65 seconds Interval 20.3 to 150.0	27.20 seconds Interval 20.1 to 150.0	25.00 seconds Interval 20.1 to 150.0	26.75 seconds Interval 20.4 to 150.0	—	—	—	—

SECONDARY outcome

Timeframe: Preoperative baseline through postoperative Day 14

Population: Safety Analysis Set

Outcome measures

Measure	FS VH S/D 500 S-apr- 60-Seconds n=21 Participants Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time	FS VH S/D 500 S-apr - 120-Seconds n=21 Participants FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group n=42 Participants Manual compression with surgical gauze pads.	Control Group n=20 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 1 n=24 Participants FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 1 n=17 Participants FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 1 n=41 Participants All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 1 n=18 Participants Manual compression with surgical gauze pads	FS 60: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 60-seconds polymerization	FS 120: Preoperative Baseline - Postoperative Day 14 FS VH S/D 500 s-apr, 120-seconds polymerization	FS All: Preoperative Baseline - Postoperative Day 14 All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time 2. FS VH S/D 500 s-apr, 120-seconds polymerization time	Control Group: Preoperative Baseline - Postoperative Day 14 Manual compression with surgical gauze pads
Laboratory Values Over Time: International Normalized Ratio (INR)	1.00 ratio Interval 0.9 to 1.2	1.10 ratio Interval 1.0 to 2.4	1.00 ratio Interval 0.9 to 2.4	1.05 ratio Interval 0.9 to 1.2	1.00 ratio Interval 0.9 to 2.1	1.00 ratio Interval 0.9 to 3.2	1.00 ratio Interval 0.9 to 3.2	1.00 ratio Interval 0.9 to 4.1	—	—	—	—

Adverse Events

Fibrin Sealant - 60 Seconds

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Fibrin Sealant - 120 Seconds

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Fibrin Sealant All - (60 + 120 Seconds)

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Control Group

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fibrin Sealant - 60 Seconds n=26 participants at risk Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time	Fibrin Sealant - 120 Seconds n=24 participants at risk FS VH S/D 500 s-apr, 120 seconds polymerization time	Fibrin Sealant All - (60 + 120 Seconds) n=50 participants at risk All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time 2. FS VH S/D 500 s-apr, 120 seconds polymerization time	Control Group n=23 participants at risk Treatment of the study-suture line will be manual compression with surgical gauze pads.
Injury, poisoning and procedural complications Graft thrombosis	3.8% 1/26 • Number of events 1 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Injury, poisoning and procedural complications Incision site haematoma	3.8% 1/26 • Number of events 1 • Throughout study period (1 year)	4.2% 1/24 • Number of events 1 • Throughout study period (1 year)	4.0% 2/50 • Number of events 2 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Metabolism and nutrition disorders Hyperglycaemia	3.8% 1/26 • Number of events 1 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Metabolism and nutrition disorders Metabolic acidosis	3.8% 1/26 • Number of events 1 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/26 • Throughout study period (1 year)	4.2% 1/24 • Number of events 1 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Injury, poisoning and procedural complications Vascular graft occlusion	0.00% 0/26 • Throughout study period (1 year)	4.2% 1/24 • Number of events 1 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Injury, poisoning and procedural complications Wound	0.00% 0/26 • Throughout study period (1 year)	4.2% 1/24 • Number of events 1 • Throughout study period (1 year)	2.0% 1/50 • Number of events 1 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Cardiac disorders Myocardial infarction	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Cardiac disorders Ventricular fibrillation	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Vascular disorders Peripheral vascular disorder	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)

Other adverse events

Measure	Fibrin Sealant - 60 Seconds n=26 participants at risk Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time	Fibrin Sealant - 120 Seconds n=24 participants at risk FS VH S/D 500 s-apr, 120 seconds polymerization time	Fibrin Sealant All - (60 + 120 Seconds) n=50 participants at risk All study participants who received Fibrin Sealant (60 + 120 Seconds): 1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time 2. FS VH S/D 500 s-apr, 120 seconds polymerization time	Control Group n=23 participants at risk Treatment of the study-suture line will be manual compression with surgical gauze pads.
Injury, poisoning and procedural complications Incision site complication	7.7% 2/26 • Number of events 3 • Throughout study period (1 year)	8.3% 2/24 • Number of events 2 • Throughout study period (1 year)	8.0% 4/50 • Number of events 5 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Injury, poisoning and procedural complications Incision site oedema	7.7% 2/26 • Number of events 2 • Throughout study period (1 year)	4.2% 1/24 • Number of events 1 • Throughout study period (1 year)	6.0% 3/50 • Number of events 3 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/26 • Throughout study period (1 year)	8.3% 2/24 • Number of events 2 • Throughout study period (1 year)	4.0% 2/50 • Number of events 2 • Throughout study period (1 year)	4.3% 1/23 • Number of events 1 • Throughout study period (1 year)
General disorders Oedema peripheral	0.00% 0/26 • Throughout study period (1 year)	8.3% 2/24 • Number of events 2 • Throughout study period (1 year)	4.0% 2/50 • Number of events 2 • Throughout study period (1 year)	8.7% 2/23 • Number of events 2 • Throughout study period (1 year)
Respiratory, thoracic and mediastinal disorders Ventricular tachycardia	0.00% 0/26 • Throughout study period (1 year)	8.3% 2/24 • Number of events 2 • Throughout study period (1 year)	4.0% 2/50 • Number of events 2 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
General disorders Pyrexia	0.00% 0/26 • Throughout study period (1 year)	8.3% 2/24 • Number of events 2 • Throughout study period (1 year)	4.0% 2/50 • Number of events 2 • Throughout study period (1 year)	0.00% 0/23 • Throughout study period (1 year)
Psychiatric disorders Anxiety	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	8.7% 2/23 • Number of events 2 • Throughout study period (1 year)
Gastrointestinal disorders Diarrhoea	0.00% 0/26 • Throughout study period (1 year)	0.00% 0/24 • Throughout study period (1 year)	0.00% 0/50 • Throughout study period (1 year)	8.7% 2/23 • Number of events 2 • Throughout study period (1 year)

Additional Information

Edith Hantak, Dir, Global Therapeutic Area, BioSurgery

BAXTER INNOVATIONS GmbH

Email: edith_hantak@baxter.com

Results disclosure agreements

• Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥45 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)
• Publication restrictions are in place

Restriction type: OTHER