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Completed

NCT Number: NCT00440401

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

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

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Key information

Conditions

Haemorrhage Cardiovascular Surgery Haemostasis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nycomed

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

fibrinogen (human) + thrombin (human)

Drug

Standard haemostatic treatment in cardiovascular surgery

Drug

Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2007
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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