Efficacy and safety of Haemocomplettan® P in patients experiencing acute bleedingwhile undergoing aortic replacement surgery - Haemocomplettan® P during aortic replacement
- Conditions
- Acute bleeding while undergoing aortic replacement surgeryMedDRA version: 9.1Level: LLTClassification code 10061651Term: Aortic surgery
- Registration Number
- EUCTR2007-004612-31-DE
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
· Eighteen years of age or older
· Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacment surgery (TAA)
· Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
· Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery
- Clinically relevant bleeding (microvasculature) defined as a 5-minute bleeding mass of 60 to 250 g
AND
- Intraoperative conditions prior to administration of study medication are
- Body temperature > 36°C
- Blood pH > 7.3
- Hb > 8.5 g/dL
- ACT < 150 seconds
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· Positive pregnancy test, pregnancy or lactation
· Women of child-bearing age not using a medically approved method of contraception during the study
· Previous aortic replacement at the same aortic site (redo surgery)
· Undergoing an emergency operation
· Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
· Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
· ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
· Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
· Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
· Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin
· Participation in another clinical study in the 4 weeks preceding aortic replacement
· Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
· Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
· Any indication that the study restrictions, procedures, or consequences therein have not been
considered or understood, such that informed consent cannot be convincingly given
· Multiple morbidities, with a notably constrained remaining length of life.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if Haemocomplettan® P effectively reduces the amount<br>of allogeneic blood products needed in patients experiencing acute<br>bleeding during aortic-replacement surgery;Secondary Objective: To determine if Haemocomplettan® P is safe and well-tolerated in<br>patients experiencing acute bleeding during aortic-replacement surgery;Primary end point(s): Combined number of units of allogeneic blood products (platelets +<br>FFP + RBCs) administered to subjects, between administration of<br>study medication and 24 hours thereafter
- Secondary Outcome Measures
Name Time Method