Status:

RECRUITING

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

Lead Sponsor:

Ankara City Hospital Bilkent

Collaborating Sponsors:

Istanbul University

Ondokuz Mayıs University

Conditions:

Massive Transfusion

Bleeding During/following Surgery

Eligibility:

All Genders

18+ years

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...

Detailed Description

Massive transfusion, defined as the transfusion of total body blood volume (10 units of erythrocyte suspension or 8 units and above in some definitions) or more within 24 hours, remains one of the gre...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • 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 Criteria
  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 7 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 30 2026

    Estimated Enrollment :

    1679 Patients enrolled

    Trial Details

    Trial ID

    NCT06021184

    Start Date

    November 7 2023

    End Date

    September 30 2026

    Last Update

    December 12 2024

    Active Locations (1)

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    Ankara Bilkent city hospital

    Ankara, çankaya, Turkey (Türkiye), 06800