A study of FGTW in the management of bleeding in Patient undergoing cardiac surgery
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of Fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB).
IRAS ID
1006165
Contact name
Evelyne Sauty
Contact email
Sponsor organisation
Laboratoire français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
Eudract number
2022-001759-17
Research summary
The purpose of this study is to assess the efficacy of FGTW (the investigational medicinal product) in combination with Standard of care (SOC), compared to placebo in combination with SOC, in reducing the need for blood products (red blood cells, plasma, platelets) transfusion after the surgery.
Fibrinogen is an essential protein for haemostasis and circulates at the highest concentration of all the coagulation proteins. During and after complex cardiac surgery, low plasma fibrinogen level may occur. Maintaining the plasma fibrinogen concentration is important to limit excessive perioperative blood loss. Complex cardiac surgery may cause excessive bleeding due to the consumption of coagulation factors involved by the activation of coagulation cascade during cardiopulmonary bypass.
Approximately 620 patients with the same condition will participate in this research study at approximately 14 study centres in Europe.
The total duration of patient’s participation in the trial will be approximately 2 months (with minimum of 6 visits), which will include up to 30 days screening period (Visit 1), surgery with a double-blind treatment administration at Visit 2, a postoperative period (Visit 3 to Visit 5) and a follow-up period after the hospital discharge (End of Study Visit).
Around 176 patients will receive one of the study drugs in the FGTW + SOC group and the placebo + SOC group, with an allocation ratio of 1:1.
Participants will undergo study assessments including, physical examination, vital signs, blood collection and ECG (Electrocardiogram).
This study is organised and funded by the sponsor LFB BIOTECHNOLOGIES.REC name
Wales REC 5
REC reference
22/WA/0262
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion