Haemocomplettan® P During Aortic Replacement

Aortic Aneurysm Clinical Trial

Official title:

Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701142
• Other study ID #: 1470
• Secondary ID: BI3023_20022007-
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2008
• Last updated: September 18, 2013
• Start date: June 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2011
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Aneurysm

Intervention

Biological:
• Haemocomplettan® P
Single intravenous infusion
• Saline solution
Single intravenous infusion

Locations

Country	Name	City	State
Germany	Medical School Hannover (MHH)	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sørensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.		From administration of Haemocomplettan® P until 24 hours later	No
Secondary	Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)		From administration of Haemocomplettan® P until 24 hours later	No
Secondary	Duration of stay in ICU		Last suture of initial surgery to end of ICU stay	No
Secondary	Duration of hospital stay		Last suture of initial surgery to end of hospital stay	No
Secondary	Mortality		45 days post surgery	No

External Links

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