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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Biological: Haemocomplettan® P; Biological: Saline solution

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Medical School Hannover (MHH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline solution	Biological: Saline solution; Single intravenous infusion
Active Comparator: Haemocomplettan® P; Intravenous infusion during aortic surgery	Biological: Haemocomplettan® P; Single intravenous infusion; Other Names: RiaSTAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.	From administration of Haemocomplettan® P until 24 hours later

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)	From administration of Haemocomplettan® P until 24 hours later
Duration of stay in ICU	Last suture of initial surgery to end of ICU stay
Duration of hospital stay	Last suture of initial surgery to end of hospital stay
Mortality	45 days post surgery

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Principal Investigator: Niels Rahe-Meyer, Dr. Dr., Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover

Publications and helpful links

General Publications

• Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d. Erratum In: Anesthesiology. 2013 May;118(5):1244.
• 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.
• Schochl 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. doi: 10.3109/00365513.2010.500396.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 16, 2008
• First Submitted That Met QC Criteria: June 18, 2008
• First Posted (Estimate): June 19, 2008

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 1470; BI3023_2002 (Other Identifier: CSL Behring); 2007-004612-31 (EudraCT Number)