Clinical Trials Logo
  1. Home
  2. Bleeding Disorder
  3. NCT03444324

Adjusted Fibrinogen Replacement Strategy — AdFIrst  

Bleeding Disorder Clinical Trial

Official title:
A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

Clinical Trial Summary

The purpose of this study is to investigate efficacy and safety of fibrinogen concentrate BT524, when administered to patients with major blood loss during elective spine surgery.The study aims to demonstrate that BT524 is at least not worse than the comparator fresh frozen plasma in reducing intra-operative blood loss.

Clinical Trial Description

Fibrinogen is the first coagulation factor to become critically reduced during intra-operative bleeding. Therefore, rapid fibrinogen supplementation to restore physiological plasma levels is an important component to achieve and maintain hemostasis in bleeding patients. In this study, patients with major blood loss during elective spine surgery will be randomized 1:1 to a single intravenous transfusion of the fibrinogen concentrate BT524 or to fibrinogen-containing fresh frozen plasma (FFP). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03444324
Study type Interventional
Source Biotest
Contact
Status Completed
Phase Phase 3
Start date February 12, 2018
Completion date October 2, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03834727 - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT00772434 - Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument N/A
Completed NCT03871452 - The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding N/A
Recruiting NCT03095625 - Role of Thromboelastography in Septic Shock N/A
Recruiting NCT04600609 - Examining the Experiences of Children With Blood Disorders
Completed NCT02979158 - Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass N/A
Active, not recruiting NCT04912336 - Extracorporeal Life Support and Modification of Hemostasis
Terminated NCT05790109 - Operator and Patient Acceptance of Radiofrequency Cautery of the Biopsy Track During Percutaneous Liver, Kidney or Spleen Biopsy Procedures. N/A
Not yet recruiting NCT05916469 - Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Recruiting NCT06250595 - European Rare Blood Disorders Platform (ENROL)
Not yet recruiting NCT06118372 - Recombinant vWF Concentrate and ECMO Phase 1
Completed NCT03355742 - XIENCE 28 Global Study N/A
Completed NCT03815175 - XIENCE 28 USA Study N/A
Completed NCT02864875 - Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial Phase 4
Completed NCT04201860 - Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds
Recruiting NCT04645199 - National Longitudinal Cohort of Hematological Diseases
Completed NCT05214300 - Screening for Bleeding Disorders in Children
Active, not recruiting NCT04188171 - Sclerotherapy With Polidocanol Foam In The Treatment Of Hemorrhoidal Disease In Patients With Bleeding Disorders Phase 2/Phase 3
Completed NCT06039904 - Protection of Knee Joints in Bleeding Disorder Patients N/A