Back to results

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

Primary Purpose

Congenital Heart Disease

Status

Unknown status

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Platelet transfusion

Fibrinogen concentrate

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Bleeding, Coagulopathy, Heart surgery, Cardiopulmonary bypass

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Platelets

Fibrinogen

Arm Description

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

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

Outcomes

Primary Outcome Measures

HEPTEM-A10

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

Secondary Outcome Measures

Amount of transfused packed red blood cells

Full Information

NCT ID

NCT04807621

First Posted

March 18, 2021

Last Updated

March 18, 2021

Sponsor

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT04807621

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 14, 2018 (Actual)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease

Keywords

Bleeding, Coagulopathy, Heart surgery, Cardiopulmonary bypass

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Platelets

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fibrinogen

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Platelet transfusion

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Fibrinogen concentrate

Intervention Description

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

Primary Outcome Measure Information:

Title

HEPTEM-A10

Description

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

Time Frame

45 minutes after intervention

Secondary Outcome Measure Information:

Title

Amount of transfused packed red blood cells

Time Frame

up to first postoperative morning

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fredrik Söderlund, MD

Phone

+46 31 343 6895

fredrik.soderlund@vgregion.se

First Name & Middle Initial & Last Name or Official Title & Degree

Birgitta Romlin, MD, PhD

Phone

+46 31 343 5370

birgitta.romlin@vgregion.se

Facility Information:

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fredrik Söderlund, MD

Phone

+46733829802

fredrik.soderlund@vgregion.se

First Name & Middle Initial & Last Name & Degree

Birgitta Romlin, MD, PhD

birgitta.romlin@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs