Haemocomplettan® P During Elective Complex Cardiac Surgery

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Fibrinogen Deficiency in Complex Cardiac Surgery
Interventions
DRUG

Haemocomplettan® P

Dosing of study medication will be individually determined based on plasma fibrinogen concentrations (measured with Clauss method during the reperfusion period on CPB) and body weight. Intravenous infusion within 10 minutes.

DRUG

Human albumin (Placebo)

Human albumin with concentration 200g/L. The study bottles of 50 mL will be diluted with saline and will contain 2g in total. This concentration resembles the total protein load in the bottles with Haemocomplettan® P.

Trial Locations (2)

8011 JW

Department Anesthesiology & Intensive Care, Zwolle

Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken, Zwolle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CSL Behring

INDUSTRY

lead

Isala

OTHER