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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Biological: Platelet transfusion; Biological: Fibrinogen concentrate

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fredrik Söderlund, MD; Phone Number: +46 31 343 6895; Email: fredrik.soderlund@vgregion.se
• Study Contact Backup: Name: Birgitta Romlin, MD, PhD; Phone Number: +46 31 343 5370; Email: birgitta.romlin@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Fredrik Söderlund, MD; Phone Number: +46733829802; Email: fredrik.soderlund@vgregion.se
    • Contact: Birgitta Romlin, MD, PhD; Email: birgitta.romlin@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelets; Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion.	Biological: Platelet transfusion; Platelets (10 ml/kg body weight) is transfused.
Experimental: Fibrinogen; Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate.	Biological: Fibrinogen concentrate; Fibrinogen concentrate (300 mg/kg body weight) is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEPTEM-A10	The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.	45 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of transfused packed red blood cells	up to first postoperative morning

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Bleeding; Cardiopulmonary bypass; Heart surgery; Coagulopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Hemorrhage; Heart Defects, Congenital
• Other Study ID Numbers: FS52016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No