Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

July 26, 2023 updated by: Denis SCHMARTZ, Brugmann University Hospital

Influence of Preoperative Fibrinogen Levels on Blood Loss and Transfusions in Pediatric Cardiac Surgery

Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels.

The aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

932

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All children under 16 year, with cardiac surgery under cardiopulmonary bypass between 2008 and 2018 at our institution

Description

Inclusion Criteria:

  • all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018
  • Age < 16 year

Exclusion Criteria:

  • preoperative coagulopathy
  • Jehovah's witnesses
  • patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Day 0
Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database
Day 0
Transfusion requirements
Time Frame: Day 0
Transfusion requirements of packed red cells ( in mL), fresh frozen plasma (in mL) and platelets (in mL) during the first 24h (day 0) will be extracted from our database
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Investigators

  • Study Director: Bernard Wenderickx, MSc, Huderf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2022

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • card_ped_fibri

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on Congenital cardiac surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe