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NCT04807621 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Official title:
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04807621
Other study ID # FS52016
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 14, 2018
Est. completion date August 2022

Study information
Verified date March 2021
Source Sahlgrenska University Hospital, Sweden
Contact Fredrik Söderlund, MD
Phone +46 31 343 6895
Email fredrik.soderlund@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date August 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility Inclusion Criteria: - Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass. - Body weight < 10 kg. - Expected CPB time > 90 minutes. Exclusion Criteria: - Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patient´s age), gestational age < 34 weeks.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Platelet transfusion
Platelets (10 ml/kg body weight) is transfused.
• Fibrinogen concentrate
Fibrinogen concentrate (300 mg/kg body weight) is administered.

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary HEPTEM-A10 The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis. 45 minutes after intervention
Secondary Amount of transfused packed red blood cells up to first postoperative morning
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