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Recruiting NCT06021184

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

Trial Parameters

Condition Massive Transfusion
Sponsor Ankara City Hospital Bilkent
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,679
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-07
Completion 2025-10-30

Brief 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.

Eligibility Criteria

Inclusion criteria 1. Age ≥ 18 2. Surgical patients who received ''Transfusion of ≥ 4 U ESs and at least one fibrinogen-containing product (FFP, fibrinogen concentrate, cryoprecipitate) within 24 hours'' 3. Elective or emergency surgical procedures with major bleeding. Major bleeding surgeries; cardiovascular and thoracic surgery, obstetric-gynecologic surgery, orthopedics/trauma surgery, neurosurgery, transplantation and major ENT-GIS-GUS surgeries. 4. Informed Consent 5. Undergoing surgery within 24 hours of massive blood transfusion Exclusion Criteria 1. Death before massive transfusion 2. Death during massive transfusion 3. Patients whose perioperative bleeding and transfusion data cannot be accessed in detail 4. Patients with missing data or non-compliance with study protocol 5. Patients who have zero ADEF/ES ratio

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