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

May 4, 2012 updated by: Nycomed

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

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Study Overview

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Roskilde, Denmark, 4000
        • Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TachoSil®
ACTIVE_COMPARATOR: Standard Treatment
Standard Treatment of haemorrhage in cardiovascular surgery
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving Haemostasis at 3 Minutes
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (ESTIMATE)

February 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • TC-023-IM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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