At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 181 enrolled
Drug / intervention
Human thrombin +1 morebiological
Likely dose
Human thrombin 1000 IUfrom 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.
A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgeries
In Brief
A Phase 2 clinical trial evaluating Human thrombin and Bovine thrombin for Hemostasis. Completed, enrolled 181 participants across 20 sites.
Detailed Summary
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedDec 18, 2013
Enrollment StartDec 1, 2013
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.5 years ago
Interventions
Human thrombinbiological
Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombinbiological
Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges