Last reviewed · How we verify
NCT06021184: ADEFES
"ADE Fibrinogen/RBC" Ratio on Mortality and Outcome in Massive Transfusion Patients
trial in Massive Transfusion in 1,679 participants. Currently enrolling.
30 October 2025
Quick facts
| Lead sponsor | Ankara City Hospital Bilkent |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,679 |
| Start date | 7 November 2023 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 September 2026 |
| Sites | 1 location across Turkey (Türkiye) |
Conditions studied
- Massive Transfusion — all drugs for Massive Transfusion →
- Bleeding During/following Surgery — all drugs for Bleeding During/following Surgery →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06021184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06021184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara City Hospital Bilkent
- Last refreshed: 12 December 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing