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RECRUITING
NCT06021184

"ADE Fibrinogen/RBC" Ratio on Mortality and Outcome in Massive Transfusion Patients

Sponsor: Ankara City Hospital Bilkent

View on ClinicalTrials.gov

Summary

Our study focuses on the transfusion of blood and blood products in cases of major bleeding, including massive transfusion scenarios where repeated doses of packed red blood cells (PRBC), fresh frozen plasma (FFP), cryoprecipitate, and fibrinogen concentrate are administered. Each of these blood products contains varying amounts of fibrinogen. Previous research has explored formulas to enhance outcomes by examining transfusion ratios such as FFP/ES, ES/platelet, and FFP/ES/platelet. Building on this, our hypothesis is that increasing the total fibrinogen content provided within a short period of time from the beginning of major bleeding reduces mortality and morbidity. To standardize the fibrinogen amounts from different sources under a single pool, we developed a formula that equalizes the fibrinogen content across these products. Using the below formula, we aim to investigate the impact of the overall ADEF/ES ratio on mortality and functional outcomes in major bleeding. Approximate Dose-Equivalent for Fibrinogen (ADE): 1 gram of fibrinogen = 5 units of cryoprecipitate = 1.5 units of FFP, evaluated as total grams of fibrinogen.

Official title: Impact of the Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) Ratio on Mortality and Functional Outcomes in Patients with Major Intraoperative Bleeding- a Prospective Observational Trial (ADEFES Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1679

Start Date

2023-11-07

Completion Date

2026-09-30

Last Updated

2024-12-12

Healthy Volunteers

No

Locations (1)

Ankara Bilkent city hospital

Ankara, çankaya, Turkey (Türkiye)