CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 97 enrolled
Drug / intervention
Thrombi-Geldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00652314
NCT00652314Phase 4Completed
CompareCT.gov

Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin

Vascular Solutions LLC·interventional·Posted Apr 3, 2008·Updated Mar 7, 2016

In Brief

A Phase 4 clinical trial evaluating Thrombi-Gel for Operation Site Bleed. Completed, enrolled 97 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOperation Site Bleed
CountriesUnited States
CollaboratorsKing Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2008
Enrollment StartMar 1, 2008
Primary CompletionOct 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.2 years ago

Interventions

Thrombi-Geldevice

Applicaton of Hemostatic product during surgery