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Haemocomplettan® P During Aortic Replacement

Sponsor
CSL Behring (Industry)
Overall Status
Completed
CT.gov ID
NCT00701142
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Haemocomplettan® P
  • Biological: Saline solution
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Haemocomplettan® P

Intravenous infusion during aortic surgery

Biological: Haemocomplettan® P
Single intravenous infusion
Other Names:
  • RiaSTAP

    		•
    Placebo Comparator: Saline solution

    Biological: Saline solution
    Single intravenous infusion

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs) [From administration of Haemocomplettan® P until 24 hours later]

    2. Duration of stay in ICU [Last suture of initial surgery to end of ICU stay]

    3. Duration of hospital stay [Last suture of initial surgery to end of hospital stay]

    4. Mortality [45 days post surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical School Hannover (MHH) Hannover Germany

    Sponsors and Collaborators

    • CSL Behring

    Investigators

    • Principal Investigator: Niels Rahe-Meyer, Dr. Dr., Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT00701142
    Other Study ID Numbers:
    • 1470
    • BI3023_2002
    • 2007-004612-31
    First Posted:
    Jun 19, 2008
    Last Update Posted:
    Sep 20, 2013
    Last Verified:
    Feb 1, 2011
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm

    Study Results

    No Results Posted as of Sep 20, 2013