Haemocomplettan® P During Aortic Replacement

NCT00701142 | Completed Phase 2

• 3 other identifiers: 1470BI3023_20022007-004612-31
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.

  From administration of Haemocomplettan® P until 24 hours later

Secondary Outcomes (4)

• 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

Study Arms (2)

Haemocomplettan® P

ACTIVE COMPARATOR

Intravenous infusion during aortic surgery

Biological: Haemocomplettan® P

Saline solution

PLACEBO COMPARATOR

Biological: Saline solution

Interventions

Haemocomplettan® P BIOLOGICAL

Single intravenous infusion

Also known as: RiaSTAP

Haemocomplettan® P

Saline solution BIOLOGICAL

Single intravenous infusion

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Medical School Hannover (MHH)

Hanover, Germany

Location

Related Publications (3)

• 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.

  PMID: 23249928 RESULT

• 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.

  PMID: 23410777 DERIVED

• 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.

  PMID: 20624109 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Fibrinogen; Saline Solution

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Niels Rahe-Meyer, Dr. Dr.

  Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 20, 2013

Record last verified: 2011-02

Locations

DE (1)