Influence of Preop Fibrinogen on Blood 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.

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrinogenemia Heart Defects, Congenital Heart Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Congenital cardiac surgery

Procedure

All children who underwent congenital cardiac surgery with cardiopulmonary bypass between 2008 and 2018

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 1, 2022
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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