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Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery

NCT04807621 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-19

No results posted yet for this study

Summary

The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.

Conditions

  • Congenital Heart Disease

Interventions

BIOLOGICAL

Platelet transfusion

Platelets (10 ml/kg body weight) is transfused.

BIOLOGICAL

Fibrinogen concentrate

Fibrinogen concentrate (300 mg/kg body weight) is administered.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2022-01-31
Completion
2022-08-31

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT04807621 on ClinicalTrials.gov