Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

Completed

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Congenital Heart Disease; Fibrinogenemia

• Registration Number: NCT05525195
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Study Start: 2022-09-17
• Primary Completion: 2023-01-25
• Study Completion: 2023-02-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 932

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood loss	Day 0	Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database
Transfusion requirements	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

Trial Locations

Locations (1)

Hôpital Universitaire des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium