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Haemocomplettan® P During Elective Complex Cardiac Surgery

NCT01124981 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-12-16

No results posted yet for this study

Summary

Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.

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.

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Isala

    lead OTHER

Principal Investigators

  • Arno P Nierich, MD, PhD. · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124981 on ClinicalTrials.gov