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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Aortic Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014