At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 31 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 Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis
In Brief
A Phase 4 clinical trial evaluating rThrombin, 1000 IU/mL for Blood Loss, Surgical. Completed, enrolled 31 participants across 1 site.
Detailed Summary
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Loss, Surgical
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartJan 2009
Primary CompletionJul 2010
TodayJul 2026
First PostedDec 23, 2008
Enrollment StartJan 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.5 years ago
Interventions
rThrombin, 1000 IU/mLbiological
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.