Haemocomplettan® P During Aortic Replacement

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

Official Title
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Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Biological: Haemocomplettan® P
* Biological: Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haemocomplettan® P<br>Intravenous infusion during aortic surgery | Biological: Haemocomplettan® P<br>* Single intravenous infusion<br>* Other names: RiaSTAP;|
| Placebo Comparator: Saline solution<br> | Biological: Saline solution<br>* Single intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. |  | From administration of Haemocomplettan® P until 24 hours later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of hospital stay |  | Last suture of initial surgery to end of hospital stay | 
| Mortality |  | 45 days post surgery |