Trial Outcomes & Findings for Progel Vascular Sealant (NCT NCT01959503)

NCT ID: NCT01959503

Last Updated: 2017-04-10

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

0 seconds to 600 seconds

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Progel Vascular Sealant Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Overall Study STARTED	107	51
Overall Study COMPLETED	104	49
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Progel Vascular Sealant Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Overall Study Death	2	1
Overall Study Randomized but not treated	1	1

Baseline Characteristics

Progel Vascular Sealant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Progel Vascular Sealant n=106 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus	Total n=156 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 14.42 • n=5 Participants	62.4 years STANDARD_DEVIATION 14.30 • n=7 Participants	61.8 years STANDARD_DEVIATION 14.34 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	15 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	35 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment United States	106 participants n=5 Participants	50 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 seconds to 600 seconds

Population: In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=105 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.	124.3 seconds Standard Deviation 202.09	377.8 seconds Standard Deviation 252.4

SECONDARY outcome

Timeframe: 5 minutes after application

Population: In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=105 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.	85.7 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: 0 seconds to 10 minutes

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=106 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.	59.4 percentage of participants	16.0 percentage of participants

SECONDARY outcome

Timeframe: 24 hours post procedure

Population: In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=106 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=49 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Chest Tube Drainage Volume Following Surgery.	701.6 mL Standard Deviation 499.83	589.6 mL Standard Deviation 359.41

SECONDARY outcome

Timeframe: 24 hours post procedure

Population: In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=106 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=49 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery	46 participants	19 participants

SECONDARY outcome

Timeframe: Intra-procedurally

Population: In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=104 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.	59.4 minutes Standard Deviation 30.96	58.5 minutes Standard Deviation 24.74

SECONDARY outcome

Timeframe: 30 days post procedure

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=106 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.	0 participants	1 participants

SECONDARY outcome

Timeframe: 30 days post procedure

Population: One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.

Outcome measures

Outcome measures
Measure	Progel Vascular Sealant n=105 Participants Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=49 Participants Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days	3 participants	4 participants

Adverse Events

Progel Vascular Sealant

Serious events: 51 serious events

Other events: 51 other events

Deaths: 0 deaths

Gelfoam Plus

Serious events: 29 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dawn Heimer

C.R. Bard

Phone: 401-825-8681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee INSTITUTION and INVESTIGATOR agree if the Study is part of a multi-center study, the first publication of the results of the Study shall be made in coajunction with the results from the investigators at the other Study centers. In the event no publication of the multi-center study has been made within two years after the completion of the Study at all Study centers, then INSTITUTION and INVESTIGATOR shall be free to publish the Study results generated.
Publication restrictions are in place

Restriction type: OTHER

Measure	Progel Vascular Sealant n=106 participants at risk Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Progel Vascular Sealant	Gelfoam Plus n=50 participants at risk Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test. Gelfoam Plus
Blood and lymphatic system disorders Anemia	32.1% 34/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	24.0% 12/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Blood and lymphatic system disorders Leukocytosis	23.6% 25/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	26.0% 13/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Blood and lymphatic system disorders Thrombocytopenia	17.9% 19/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	14.0% 7/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Cardiac disorders Atrial Fibrillation	12.3% 13/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	14.0% 7/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Cardiac disorders Tachycardia	5.7% 6/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	4.0% 2/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Gastrointestinal disorders Nausea	14.2% 15/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	14.0% 7/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Gastrointestinal disorders Vomiting	0.94% 1/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	8.0% 4/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
General disorders Fatigue	2.8% 3/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	10.0% 5/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
General disorders Oedema Peripheral	17.0% 18/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	8.0% 4/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
General disorders Pyrexia	1.9% 2/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Metabolism and nutrition disorders Fluid Overload	9.4% 10/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	16.0% 8/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Metabolism and nutrition disorders Hyperglycemia	7.5% 8/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	10.0% 5/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Metabolism and nutrition disorders Hypokalemia	6.6% 7/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	4.0% 2/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Metabolism and nutrition disorders Hyponatremia	2.8% 3/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Musculoskeletal and connective tissue disorders Back Pain	6.6% 7/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	4.0% 2/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	1.9% 2/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	8.0% 4/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Nervous system disorders Dizziness	5.7% 6/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Renal and urinary disorders Renal Injury	4.7% 5/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Atelectasis	34.0% 36/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	30.0% 15/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 4/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.7% 6/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	35.8% 38/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	34.0% 17/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.7% 6/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	9.4% 10/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	4.0% 2/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.8% 3/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	6.0% 3/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.
Vascular disorders Hypotension	12.3% 13/106 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.	8.0% 4/50 • Incidence of reoperations for aortic bleeding complications following assigned treatment through 30 days. Number of device-related serious adverse events per patient following assigned treatment through 30 days.