Impact of Fibrinogen and RBC Ratio on Outcomes in Major Bleeding
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)
This study is testing if the way we mix fibrinogen and red blood cells during blood transfusions can help patients who are bleeding heavily during surgery have better recovery and survival rates.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1679 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Trial ID | NCT06021184 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transfusion ratios of fibrinogen and red blood cells in patients experiencing massive bleeding during surgery. It aims to standardize the fibrinogen content from various blood products and assess how this affects mortality and functional outcomes. By analyzing the ADEF/ES ratio, the study seeks to improve management protocols for massive transfusions in surgical settings. The research focuses on patients who have received significant blood transfusions and aims to enhance treatment strategies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing elective or emergency surgeries that require significant blood transfusions.
Not a fit: Patients who die before or during massive transfusion or those with incomplete data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and recovery outcomes for patients undergoing major surgeries with massive bleeding.
How similar studies have performed: Previous studies have explored transfusion ratios in massive bleeding, indicating potential for success, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara, Çankaya
- Ankara Bilkent city hospital — Ankara, Çankaya, Turkey (Recruiting)
Study contacts
- Study coordinator: Zeliha Aslı Demir, Prof
- Email: zaslidem@yahoo.com
- Phone: +905052491598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.