Haemocomplettan® P During Aortic Replacement
Information source: CSL Behring
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Aneurysm
Intervention: Haemocomplettan® P (Biological); Saline solution (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: CSL Behring Official(s) and/or principal investigator(s):
Niels Rahe-Meyer, Dr. Dr., Principal Investigator, Affiliation: Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
Overall contact:
Central Contact: Clinical Trial Registration Coordinator, Email: clinicaltrials@cslbehring.com
Summary
The primary purpose is to show that administration of Haemocomplettan® P significantly
reduces the amount of blood products needed during aortic surgery.
Clinical Details
Official title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Secondary outcome: Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)Duration of stay in ICU Duration of hospital stay Mortality
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Central Contact: Clinical Trial Registration Coordinator, Email: clinicaltrials@cslbehring.com
Medical School Hannover (MHH), Hannover, Germany; Recruiting
Additional Information
Starting date: June 2008
Ending date: May 2010
Last updated: July 3, 2009
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