Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

NCT05525195 | Completed

• 1 other identifier: card_ped_fibri
• Study Type: observational
• Target: 932
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Congenital Heart Disease; Cardiopulmonary Bypass; Fibrinogenemia

Outcome Measures

Primary Outcomes (2)

• Blood loss

  Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database

  Day 0

• Transfusion requirements

  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

Interventions

Congenital cardiac surgery PROCEDURE

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

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Related Publications (20)

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  PMID: 25600583 BACKGROUND

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  PMID: 17442904 BACKGROUND

• Willems A, Harrington K, Lacroix J, Biarent D, Joffe AR, Wensley D, Ducruet T, Hebert PC, Tucci M; TRIPICU investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Comparison of two red-cell transfusion strategies after pediatric cardiac surgery: a subgroup analysis. Crit Care Med. 2010 Feb;38(2):649-56. doi: 10.1097/CCM.0b013e3181bc816c.

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MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bernard Wenderickx, MSc

  HUDERF

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, anesthesiology

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: September 17, 2022
• Primary Completion: January 25, 2023
• Study Completion: February 10, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)