At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
fibrinogen (human) + thrombin (human) +1 moredrug
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 Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery
In Brief
A Phase 4 clinical trial evaluating fibrinogen (human) + thrombin (human) and Standard haemostatic treatment in cardiovascular surgery for Haemorrhage and 2 related conditions. Completed, enrolled 120 participants across 1 site.
Detailed Summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemorrhage, Haemostasis, Cardiovascular Surgery
CountriesDenmark
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionAug 2007
Study CompletionNov 2007
TodayJul 2026
First PostedFeb 27, 2007
Enrollment StartFeb 1, 2007
Primary CompletionAug 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.3 years ago
Interventions
fibrinogen (human) + thrombin (human)drug
Standard haemostatic treatment in cardiovascular surgerydrug
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)