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NCT06021184: ADEFES

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

Recruiting now Last updated 12 December 2024
What this trial tests

trial in Massive Transfusion in 1,679 participants. Currently enrolling.

Timeline
7 November 2023
Primary endpoint
30 October 2025
30 September 2026

Quick facts

Lead sponsorAnkara City Hospital Bilkent
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment1,679
Start date7 November 2023
Primary completion30 October 2025
Estimated completion30 September 2026
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

Ankara City Hospital Bilkent

Who can join

18 and older, any sex, with Massive Transfusion or Bleeding During/following Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impact of fibrinogen-to-erythrocyte suspension ratio on mortality and functional outcomes in major perioperative bleeding (Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) study): protocol for a prospective observational study.
    Demir ZA, Kavak Akelma F, Akça O, Koltka K, et al · · 2025 · PMID 40962355 · DOI 10.1136/bmjopen-2025-099044

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Other Ankara City Hospital Bilkent trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06021184.

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