Haemocomplettan® P During Aortic Replacement - Full Text View

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:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

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:

Click here to request more information about this study This link exits the ClinicalTrials.gov site

No publications provided by CSL Behring

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083.

Schöchl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7.

Responsible Party:	Global Head Clinical Research & Development, 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:	February 10, 2011
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 May 23, 2013