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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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, 2007-004612-31
Study First Received: June 16, 2008
Last Updated: September 18, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on April 17, 2014