Phase 4
N=119
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
Haemorrhage · Haemostasis · Cardiovascular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00440401 ↗Enrolled (actual)
119
Serious AEs
21.9%
Results posted
Jun 2010
Primary outcome: Primary: Proportion of Subjects Achieving Haemostasis at 3 Minutes — 0.746; 0.333 Proportion of Subjects — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fibrinogen (human) + thrombin (human) (Drug); Standard haemostatic treatment in cardiovascular surgery (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nycomed
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Haemostasis at 3 Minutes |
0.746; 0.333 | <0.0001 sig |
| SECONDARY Proportion of Subjects Achieving Haemostasis at 6 Minutes. |
0.949; 0.717 | <0.0006 sig |
Summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
Eligibility Criteria
Inclusion Criteria
All inclusion criteria must be answered "yes" for a subject to participate in the trial.
At Screening:
- Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
- For female subjects of childbearing potential: Is the pregnancy test at screening negative?
- Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
- Is the subject ≥ 18 years of age?
- Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?
Intra operative (after primary haemostatic treatment):
- Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
- Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
- Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?
Exclusion Criteria
All exclusion criteria must be answered "no" for a subject to participate in the trial.
At Screening:
- Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
- Does the subject participate in a clinical trial concomitantly with the present trial?
- Is the subject undergoing an emergency operation?
- Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- Is the subject suffering from known coagulopathy?
- Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
- Is the female subject pregnant or breast feeding?
Intra operative (after primary haemostatic treatment):
- Has liquid fibrin sealant/glue or TachoSil® been applied?
- Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?
Data sourced from ClinicalTrials.gov (NCT00440401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.