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Haemocomplettan® P During Aortic Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00701142
First received: June 16, 2008
Last updated: September 18, 2013
Last verified: February 2011

June 16, 2008
September 18, 2013
June 2008
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00701142 on ClinicalTrials.gov Archive Site
  • Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs) [ Time Frame: From administration of Haemocomplettan® P until 24 hours later ] [ Designated as safety issue: No ]
  • Duration of stay in ICU [ Time Frame: Last suture of initial surgery to end of ICU stay ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: Last suture of initial surgery to end of hospital stay ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 45 days post surgery ] [ Designated as safety issue: No ]
  • Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs) [ Time Frame: From administration of Haemocomplettan® P until 24 hours later ] [ Designated as safety issue: No ]
  • Duration of stay in ICU following last suture of initial surgery [ Designated as safety issue: No ]
  • Duration of hospital stay following last suture of initial surgery [ Designated as safety issue: No ]
  • Mortality at 45 days post surgery [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Haemocomplettan® P During Aortic Replacement
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Aortic Aneurysm
  • Biological: Haemocomplettan® P
    Single intravenous infusion
    Other Name: RiaSTAP
  • Biological: Saline solution
    Single intravenous infusion
  • Active Comparator: Haemocomplettan® P
    Intravenous infusion during aortic surgery
    Intervention: Biological: Haemocomplettan® P
  • Placebo Comparator: Saline solution
    Intervention: Biological: Saline solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00701142
1470, BI3023_2002, 2007-004612-31
No
CSL Behring
CSL Behring
Not Provided
Principal Investigator: Niels Rahe-Meyer, Dr. Dr. Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
CSL Behring
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP