Haemocomplettan® P During Aortic Replacement

CSL Behring

Status and phase

Completed

Phase 2

Conditions

Aortic Aneurysm

Treatments

Biological: Saline solution

Biological: Haemocomplettan® P

Study type

Interventional

Funder types

Industry

Identifiers

NCT00701142

BI3023_2002 (Other Identifier)

2007-004612-31 (EudraCT Number)

1470

Details and patient eligibility

About

The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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