RecruitingNCT06021184

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

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)


Sponsor

Ankara City Hospital Bilkent

Enrollment

1,679 participants

Start Date

Nov 7, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥ 18
  • Surgical patients who received ''Transfusion of ≥ 4 U ESs and at least one fibrinogen-containing product (FFP, fibrinogen concentrate, cryoprecipitate) within 24 hours''
  • 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.
  • Informed Consent
  • Undergoing surgery within 24 hours of massive blood transfusion

Exclusion Criteria5

  • Death before massive transfusion
  • Death during massive transfusion
  • Patients whose perioperative bleeding and transfusion data cannot be accessed in detail
  • Patients with missing data or non-compliance with study protocol
  • Patients who have zero ADEF/ES ratio

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Locations(1)

Ankara Bilkent city hospital

Ankara, çankaya, Turkey (Türkiye)

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NCT06021184


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