Status:
COMPLETED
Haemocomplettan® P During Aortic Replacement
Lead Sponsor:
CSL Behring
Conditions:
Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Eligibility Criteria
Inclusion
- Eighteen years of age or older
- Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement 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
Exclusion
- 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 surgeries)
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00701142
Start Date
June 1 2008
End Date
April 1 2010
Last Update
September 20 2013
Active Locations (1)
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1
Medical School Hannover (MHH)
Hanover, Germany