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Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05525195
Enrollment
932
Registered
2022-09-01
Start date
2022-09-17
Completion date
2023-02-10
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Disease, Fibrinogenemia

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.

Interventions

PROCEDURECongenital cardiac surgery

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

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026