NCT00701142CompletedPhase 2
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- CSL Behring
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Study Overview
Brief Summary
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline solution
Placebo Comparator
Intervention: Saline solution (Biological)
Haemocomplettan® P
Active Comparator
Intravenous infusion during aortic surgery
Intervention: Haemocomplettan® P (Biological)
Outcomes
Primary Outcomes
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Time Frame: From administration of Haemocomplettan® P until 24 hours later
Secondary Outcomes
- Duration of hospital stay(Last suture of initial surgery to end of hospital stay)
- Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)(From administration of Haemocomplettan® P until 24 hours later)
- Duration of stay in ICU(Last suture of initial surgery to end of ICU stay)
- Mortality(45 days post surgery)
Investigators
Study Sites (1)
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