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

Cardiovascular Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440401
• Other study ID #: TC-023-IM
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2007
• Last updated: May 4, 2012
• Start date: February 2007
• Est. completion date: November 2007

Study information

• Verified date: July 2010
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All inclusion criteria must be answered "yes" for a subject to participate in the trial.

At Screening:

1. 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.

2. For female subjects of childbearing potential: Is the pregnancy test at screening negative?

3. Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?

4. Is the subject = 18 years of age?

5. 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):

6. Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?

7. Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).

8. 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:

1. Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?

2. Does the subject participate in a clinical trial concomitantly with the present trial?

3. Is the subject undergoing an emergency operation?

4. Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?

5. Is the subject suffering from known coagulopathy?

6. Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?

7. Is the female subject pregnant or breast feeding?

Intra operative (after primary haemostatic treatment):

8. Has liquid fibrin sealant/glue or TachoSil® been applied?

9. Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Surgery
• Haemorrhage
• Haemostasis
• Hemorrhage

Intervention

Drug:
• fibrinogen (human) + thrombin (human)

• Standard haemostatic treatment in cardiovascular surgery
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

Locations

Country	Name	City	State
Denmark	Nycomed	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes