Platelets or Fibrinogen as First-line Treatment for Bleed... | NCT04807621

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

NCT04807621

Sponsor

Sahlgrenska University Hospital

Status

Unknown status

Last Update Posted

Mar 19, 2021Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Congenital Heart Disease

Interventions

Platelet transfusion
Fibrinogen concentrate

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2018Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

Mar 18, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fredrik Söderlund, Consultant, Anaesthesia and Intensive Care, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Platelet transfusion	Biological	Platelets (10 ml/kg body weight) is transfused.	Platelets

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital	Recruiting	Gothenburg			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital
D006470	Hemorrhage
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017713	Platelet Transfusion
D005340	Fibrinogen

Ancestor Terms

ID	Term
D016913	Blood Component Transfusion
D001803	Blood Transfusion
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided