A Phase 4 interventional study of Thrombi-Gel in Operation Site Bleed, sponsored by Vascular Solutions LLC. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-07.
Sponsored by Vascular Solutions LLC · Phase 4, Interventional, and Supportive care
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.
This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an absorbable hemostat in the surgical patient population.
Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization.
A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 97 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Vascular Solutions LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria to be determined during the surgical procedure:
Exclusion Criteria:
Thrombi-gel treatment
Device: Thrombi-Gel
Gelatin Sponge (Gelfoam) plus thrombin
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
Also known as: Gelatin Sponge (Gelfoam) plus thrombin
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.
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.
Time frame: Time to hemostasis (minutes)
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)
Time frame: Procedure, up to 6 minutes post procedure
Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire)
Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.
Time frame: Procedure (application through end of procedure)
Safety: Incidence Rate of Device-related Adverse Events
Time frame: Procedure, up to 60 days post procedure
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Time frame: 0 day, 30 day, and 60 days post procedure
| Milestone | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| Started | 62 | 35 |
| Completed | 53 | 26 |
| Not completed | 9 | 9 |
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.
| Time to hemostasis (minutes) | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| 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 ± 4.15 | 3.72 ± 4.75 |
| participants | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| 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 | 29 |
Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.
| participants | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| Ease of application to bleeding site - 1 (easy) | 57 | 29 |
| Ease of application to bleeding site - 2 | 5 | 4 |
| Ease of application to bleeding site - 3 | 0 | 0 |
| Ease of application to bleeding site - 4 | 0 | 0 |
| Ease of application to bleeding site - 5 (hard) | 0 | 0 |
| Conformance to tissue surfaces - 1 (well) | 47 | 28 |
| Conformance to tissue surfaces - 2 | 15 | 4 |
| Conformance to tissue surfaces - 3 | 0 | 1 |
| Conformance to tissue surfaces - 4 | 0 | 0 |
| Conformance to tissue surfaces - 5 | 0 | 0 |
| Ease of delivery to hard to reach surfaces-1(easy) | 38 | 24 |
| Ease of delivery to hard to reach surfaces - 2 | 14 | 5 |
| Ease of delivery to hard to reach surfaces - 3 | 3 | 1 |
| Ease of delivery to hard to reach surfaces - 4 | 0 | 0 |
| Ease of delivery to hard to reach surfaces-5(hard) | 0 | 0 |
| Ease of preparation for use - 1 (easy) | 56 | 24 |
| Ease of preparation for use - 2 | 4 | 3 |
| Ease of preparation for use - 3 | 2 | 6 |
| Ease of preparation for use - 4 | 0 | 0 |
| Ease of preparation for use - 5 | 0 | 0 |
| participants | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| Serious | 2 | 0 |
| Non-Serious | 1 | 0 |
| participants | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| Bovine FV/Va (0 Day) | 11 | 3 |
| Bovine FV/Va (30 Day) | 17 | 9 |
| Bovine FV/Va (60 Day) | 11 | 7 |
| Bovine Thrombin (0 Day) | 12 | 4 |
| Bovine Thrombin (30 Day) | 15 | 7 |
| Bovine Thrombin (60 Day) | 14 | 4 |
| Human FV/Va (0 Day) | 9 | 7 |
| Human FV/Va (30 Day) | 12 | 10 |
| Human FV/Va (60 Day) | 10 | 5 |
| Human Thrombin (0 Day) | 3 | 2 |
| Human Thrombin (30 Day) | 7 | 3 |
| Human Thrombin (60 Day) | 4 | 3 |
Collected over 60-Day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 - Thrombi-gel Treatment | — | 11/62 (17.7%) | 33/62 (53.2%) |
| 2 - Gelatin Sponge (Gelfoam) Plus Thrombin | — | 5/35 (14.3%) | 22/35 (62.9%) |
| Event | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| OtherGeneral disorders | 6/62 | 4/35 |
| Abnormal ThrombosisBlood and lymphatic system disorders | 2/62 | 0/35 |
| Infection/AbscessInfections and infestations | 2/62 | 1/35 |
| HematomaBlood and lymphatic system disorders | 1/62 | 0/35 |
| Event | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin |
|---|---|---|
| OtherGeneral disorders | 32/62 | 22/35 |
| Foreign Body / Hypersensitivity Reaction / Allergic ReactionImmune system disorders | 1/62 | 2/35 |
| Infection/AbscessInfections and infestations | 1/62 | 1/35 |
| Tissue NecrosisMusculoskeletal and connective tissue disorders | 0/62 | 1/35 |
| Age, Customized(participants) | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin | Total |
|---|---|---|---|
| >= to 18 Years | 62 | 35 | 97 |
| Sex: Female, Male(Participants) | 1 - Thrombi-gel Treatment | 2 - Gelatin Sponge (Gelfoam) Plus Thrombin | Total |
|---|---|---|---|
| Female | 37 | 21 | 58 |
| Male | 25 | 14 | 39 |
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