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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00440401
First received: February 26, 2007
Last updated: May 4, 2012
Last verified: July 2010
  Purpose

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery


Condition Intervention Phase
Haemorrhage
Haemostasis
Cardiovascular Surgery
Drug: fibrinogen (human) + thrombin (human)
Drug: Standard haemostatic treatment in cardiovascular surgery
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Proportion of Subjects Achieving Haemostasis at 3 Minutes [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
    Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.


Secondary Outcome Measures:
  • Proportion of Subjects Achieving Haemostasis at 6 Minutes. [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]
    Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.


Enrollment: 120
Study Start Date: February 2007
Study Completion Date: November 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TachoSil® Drug: fibrinogen (human) + thrombin (human)
Active Comparator: Standard Treatment
Standard Treatment of haemorrhage in cardiovascular surgery
Drug: Standard haemostatic treatment in cardiovascular surgery
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440401

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00440401     History of Changes
Other Study ID Numbers: TC-023-IM
Study First Received: February 26, 2007
Results First Received: May 7, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Nycomed:
Surgical treatment of haemorrhage

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014