TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)

Study Overview
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Brief Summary
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To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Official Title
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A Randomised, Open Label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety of TachoSil® Versus Standard Haemostatic Treatment in Cardiovascular Surgery

Conditions
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Haemorrhage, Haemostasis, Cardiovascular Surgery

Intervention / Treatment
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* Drug: fibrinogen (human) + thrombin (human)
* Drug: Standard haemostatic treatment in cardiovascular surgery


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TachoSil®<br> | Drug: fibrinogen (human) + thrombin (human)<br> <br> |
| Active Comparator: Standard Treatment<br>Standard Treatment of haemorrhage in cardiovascular surgery | Drug: Standard haemostatic treatment in cardiovascular surgery<br>* Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Haemostasis at 3 Minutes | Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Haemostasis at 6 Minutes. | Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved. | 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical treatment of haemorrhage