Back to resultsTachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
Primary Purpose
Haemorrhage, Haemostasis, Cardiovascular Surgery
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
fibrinogen (human) + thrombin (human)
Standard haemostatic treatment in cardiovascular surgery
Sponsored by
About this trial
This is an interventional treatment trial for Haemorrhage focused on measuring Surgical treatment of haemorrhage
Eligibility Criteria
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?
Sites / Locations
- Nycomed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TachoSil®
Standard Treatment
Arm Description
Standard Treatment of haemorrhage in cardiovascular surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00440401
Brief Title
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nycomed
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemorrhage, Haemostasis, Cardiovascular Surgery
Keywords
Surgical treatment of haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TachoSil®
Arm Type
Active Comparator
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Standard Treatment of haemorrhage in cardiovascular surgery
Intervention Type
Drug
Intervention Name(s)
fibrinogen (human) + thrombin (human)
Intervention Type
Drug
Intervention Name(s)
Standard haemostatic treatment in cardiovascular surgery
Intervention Description
Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving Haemostasis at 3 Minutes
Description
Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving Haemostasis at 6 Minutes.
Description
Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed Clinical Trial Operations
Organizational Affiliation
Headquaters
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
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