CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 932 enrolled
Drug / intervention
Congenital cardiac surgeryprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05525195
NCT05525195N/ACompleted

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

Brugmann University Hospital·observational·Posted Sep 1, 2022·Updated Jul 27, 2023

In Brief

An observational study evaluating Congenital cardiac surgery for Cardiac Surgery and 3 related conditions. Completed, enrolled 932 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 1, 2022
Enrollment StartSep 17, 2022
Primary CompletionJan 25, 2023
Study CompletionFeb 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.8 years ago

Interventions

Congenital cardiac surgeryprocedure

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