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Haemocomplettan® P During Aortic Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701142
First Posted: June 19, 2008
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CSL Behring
  Purpose
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.

Condition Intervention Phase
Aortic Aneurysm Biological: Haemocomplettan® P Biological: Saline solution Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Duration of stay in ICU [ Time Frame: Last suture of initial surgery to end of ICU stay ]
  • Duration of hospital stay [ Time Frame: Last suture of initial surgery to end of hospital stay ]
  • Mortality [ Time Frame: 45 days post surgery ]

Enrollment: 80
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Haemocomplettan® P
Intravenous infusion during aortic surgery
Biological: Haemocomplettan® P
Single intravenous infusion
Other Name: RiaSTAP
Placebo Comparator: Saline solution Biological: Saline solution
Single intravenous infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701142


Locations
Germany
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
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00701142     History of Changes
Other Study ID Numbers: 1470
BI3023_2002 ( Other Identifier: CSL Behring )
2007-004612-31 ( EudraCT Number )
First Submitted: June 16, 2008
First Posted: June 19, 2008
Last Update Posted: September 20, 2013
Last Verified: February 2011

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases


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