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Fibrinogen Concentrate In Children After Cardiac Surgery

NCT01187225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2013-01-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.

Conditions

  • Cardiac Surgical Procedures
  • Blood Coagulation Disorders
  • Fibrinogen
  • Cryoprecipitate

Interventions

DRUG

Fibrinogen concentrate

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

DRUG

Cryoprecipitate

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-01-31
Completion
2011-11-30

Countries

  • Brazil

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 NCT01187225 on ClinicalTrials.gov