Trial Outcomes & Findings for Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin (NCT NCT00652314)
NCT ID: NCT00652314
Last Updated: 2016-03-07
Results Overview
Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
Time to hemostasis (minutes)
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
1 - Thrombi-gel Treatment
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
35
|
|
Overall Study
COMPLETED
|
53
|
26
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
Baseline characteristics by cohort
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= to 18 Years
|
62 participants
n=5 Participants
|
35 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time to hemostasis (minutes)Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.
Outcome measures
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.
|
4.01 Time to hemostasis (minutes)
Standard Deviation 4.15
|
3.72 Time to hemostasis (minutes)
Standard Deviation 4.75
|
SECONDARY outcome
Timeframe: Procedure, up to 6 minutes post procedureOutcome measures
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)
|
50 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Procedure (application through end of procedure)Population: Note that the number of participants analyzed (62 and 33) applies to each set of five rows below which apply to the following categories: Ease of application to bleeding site, conformance to tissue surfaces, ease of delivery to hard to reach surfaces, and ease of preparation for use.
Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.
Outcome measures
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=33 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site - 2
|
5 participants
|
4 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site - 3
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site - 1 (easy)
|
57 participants
|
29 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site - 4
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site - 5 (hard)
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Conformance to tissue surfaces - 1 (well)
|
47 participants
|
28 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Conformance to tissue surfaces - 2
|
15 participants
|
4 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Conformance to tissue surfaces - 3
|
0 participants
|
1 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Conformance to tissue surfaces - 4
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Conformance to tissue surfaces - 5
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of delivery to hard to reach surfaces-1(easy)
|
38 participants
|
24 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of delivery to hard to reach surfaces - 2
|
14 participants
|
5 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of delivery to hard to reach surfaces - 3
|
3 participants
|
1 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of delivery to hard to reach surfaces - 4
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of delivery to hard to reach surfaces-5(hard)
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of preparation for use - 1 (easy)
|
56 participants
|
24 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of preparation for use - 2
|
4 participants
|
3 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of preparation for use - 3
|
2 participants
|
6 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of preparation for use - 4
|
0 participants
|
0 participants
|
|
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of preparation for use - 5
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Procedure, up to 60 days post procedureOutcome measures
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Safety: Incidence Rate of Device-related Adverse Events
Serious
|
2 participants
|
0 participants
|
|
Safety: Incidence Rate of Device-related Adverse Events
Non-Serious
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 day, 30 day, and 60 days post procedureOutcome measures
| Measure |
1 - Thrombi-gel Treatment
n=62 Participants
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 Participants
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine FV/Va (60 Day)
|
11 participants
|
7 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine FV/Va (0 Day)
|
11 participants
|
3 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine FV/Va (30 Day)
|
17 participants
|
9 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine Thrombin (0 Day)
|
12 participants
|
4 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine Thrombin (30 Day)
|
15 participants
|
7 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Bovine Thrombin (60 Day)
|
14 participants
|
4 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human FV/Va (0 Day)
|
9 participants
|
7 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human FV/Va (30 Day)
|
12 participants
|
10 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human FV/Va (60 Day)
|
10 participants
|
5 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human Thrombin (0 Day)
|
3 participants
|
2 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human Thrombin (30 Day)
|
7 participants
|
3 participants
|
|
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Human Thrombin (60 Day)
|
4 participants
|
3 participants
|
Adverse Events
1 - Thrombi-gel Treatment
Serious events: 11 serious events
Other events: 33 other events
Deaths: 0 deaths
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 - Thrombi-gel Treatment
n=62 participants at risk
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 participants at risk
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal Thrombosis
|
3.2%
2/62 • Number of events 2 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
0.00%
0/35 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
Blood and lymphatic system disorders
Hematoma
|
1.6%
1/62 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
0.00%
0/35 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
Infections and infestations
Infection/Abscess
|
3.2%
2/62 • Number of events 3 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
2.9%
1/35 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
General disorders
Other
|
9.7%
6/62 • Number of events 7 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
11.4%
4/35 • Number of events 4 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
Other adverse events
| Measure |
1 - Thrombi-gel Treatment
n=62 participants at risk
Thrombi-gel treatment
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
2 - Gelatin Sponge (Gelfoam) Plus Thrombin
n=35 participants at risk
Gelatin Sponge (Gelfoam) plus thrombin
Thrombi-Gel: Applicaton of Hemostatic product during surgery
|
|---|---|---|
|
Immune system disorders
Foreign Body / Hypersensitivity Reaction / Allergic Reaction
|
1.6%
1/62 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
5.7%
2/35 • Number of events 2 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
Infections and infestations
Infection/Abscess
|
1.6%
1/62 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
2.9%
1/35 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
General disorders
Other
|
51.6%
32/62 • Number of events 68 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
62.9%
22/35 • Number of events 56 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
|
Musculoskeletal and connective tissue disorders
Tissue Necrosis
|
0.00%
0/62 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
2.9%
1/35 • Number of events 1 • 60-Day
Adverse events reviewed by an independent clinical events committee (CEC).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60