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

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.

Conditions

• Massive Transfusion
• Bleeding During/Following Surgery

Sponsors & Collaborators

• Istanbul University

  collaborator OTHER

• Ondokuz Mayıs University

  collaborator OTHER

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

  collaborator OTHER

• Kanuni Sultan Suleyman Training and Research Hospital

  collaborator OTHER

• Saglik Bilimleri Universitesi

  collaborator OTHER

• Acibadem Atakent University Hospital

  collaborator OTHER

• Bursa Sevket Yilmaz Training and Research Hospital

  collaborator OTHER_GOV

• Başakşehir Çam & Sakura City Hospital

  collaborator OTHER_GOV

• Ataturk University

  collaborator OTHER

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

  collaborator OTHER_GOV

• Gazi University

  collaborator OTHER

• Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

  collaborator OTHER

• Van Yüzüncü Yıl Üniversitesi Dursun Odabaşı Tıp Merkezi

  collaborator UNKNOWN

• Cukurova University Medical Faculty Hospital

  collaborator UNKNOWN

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

  collaborator OTHER

• Suleyman Demirel University

  collaborator OTHER

• Ankara City Hospital Bilkent

  lead OTHER

Principal Investigators

• Kemalettin Koltka, Prof · Istanbul University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-07

Primary Completion

2026-04-30

Completion

2026-09-30

Countries

• Turkey (Türkiye)

Study Locations