At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
rThrombin, 1000 IU/mLbiological
Likely dose
rThrombin, 1000 IU/mLfrom 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 Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting
In Brief
A Phase 4 clinical trial evaluating rThrombin, 1000 IU/mL for Blood Loss, Surgical. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Loss, Surgical
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedMar 11, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.3 years ago
Interventions
rThrombin, 1000 IU/mLbiological
rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.