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

NCT04807621 | Unknown Phase 2

• 1 other identifier: FS52016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bleeding; Coagulopathy; Heart surgery; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• HEPTEM-A10

  The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.

  45 minutes after intervention

Secondary Outcomes (1)

• Amount of transfused packed red blood cells

  up to first postoperative morning

Study Arms (2)

Platelets

ACTIVE COMPARATOR

Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion.

Biological: Platelet transfusion

Fibrinogen

EXPERIMENTAL

Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate.

Biological: Fibrinogen concentrate

Interventions

Platelet transfusion BIOLOGICAL

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

Platelets

Fibrinogen concentrate BIOLOGICAL

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

Fibrinogen

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Hemorrhage; Hemostatic Disorders

Interventions

Platelet Transfusion; Fibrinogen

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics; Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Central Study Contacts

Fredrik Söderlund, MD

CONTACT

+46 31 343 6895; fredrik.soderlund@vgregion.se

Birgitta Romlin, MD, PhD

CONTACT

+46 31 343 5370; birgitta.romlin@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anaesthesia and Intensive Care

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: March 14, 2018
• Primary Completion: January 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)