Haemocomplettan® P During Aortic Replacement

Phase 2

Completed

• Conditions: Aortic Aneurysm
• Interventions: Biological: Saline solution; Biological: Haemocomplettan® P

• Registration Number: NCT00701142
• Lead Sponsor: CSL Behring

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2011-02
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution	Saline solution	-
Haemocomplettan® P	Haemocomplettan® P	Intravenous infusion during aortic surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 hospital stay	Last suture of initial surgery to end of hospital stay
Duration of stay in ICU	Last suture of initial surgery to end of ICU stay
Mortality	45 days post surgery

Trial Locations

Locations (1)

Medical School Hannover (MHH); 🇩🇪 Hannover, Germany