At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 234 enrolled
Drug / intervention
rThrombinbiological
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.
A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis
In Brief
A Phase 3 clinical trial evaluating rThrombin for Spinal Surgery and Vascular Surgery. Completed, enrolled 234 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Surgery, Vascular Surgery
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionJul 2008
TodayJul 2026
First PostedJun 26, 2007
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.0 years ago
Interventions
rThrombinbiological
1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder