An international randomised, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dosing regimens of FIBRINOGENE T1 in the treatment of peri-operative bleeding associated with revision total hip arthroplasty

• Conditions: Severe Acute Haemorrhage (SAH)The main clinical situations of SAH are trauma and surgery-related haemorrhages and obstretical haemorrheges. Othopedic procedures can induce SAH. One of the most haemorrhagic types of surgery is revision total hip arthroplasty (THA). For the purpose of the study patient with elective revision THA including major acetabular and/or femoral reconstruction.; MedDRA version: 9.1Level: LLTClassification code 10066691Term: Acute haemorrhage

• Registration Number: EUCTR2008-007110-29-FR
• Lead Sponsor: FB BIOTECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Signed and dated informed consent form,
2.Age > 18 years old,
3.For women of childbearing potential, a pregnancy test before inclusion and a medically acceptable method of birth control throughout the study are required,
4.Known serology status (including vaccination),
5.Elective revision THA including major acetabular and/or femoral reconstruction,
6.Covered by healthcare insurance in accordance with local requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Congenital bleeding disorder,
2.Personal history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis),
3.Anaemia (Hb < 10 g/dL),
4.Total white blood cells > 12000 cells/mm3,
5.Platelets < 100 G/L,
6.Plasma fibrinogen concentration > 4 g/L,
7.Revision of infected THA,
8.Plasma creatinine > 120 µmol/mL
9.Pregnancy or breastfeeding,
10.Known history of hypersensitivity or other severe reaction to any component of the investigational medicinal products, including placebo or any component, administered during the study,
11.Treatment with any investigational medicinal product or participation in another clinical study within 30 days prior to screening,
12.Previously randomised in this clinical study,
13.Known neoplastic disorder that is currently active or currently treated with a drug known to have a thrombotic effect,
14.Current clinically significant gastrointestinal, neurological, renal, hepatic, endocrine, cardiac or pulmonary disease, diabetes, hypertension, asthma or COPD that is not well controlled,
15.Tranexamic acid use,
16.Erythropoietin use within 3 months prior to screening and during study,
17.Drug or alcohol abuse,
18.Patients with abnormalities in physical examination or laboratory results that, in the opinion of the Investigator, are deemed to be clinically significant,
19.Patients whose use of concomitant medication may interfere with the interpretation of data,
20.Anticipated poor compliance of patient with study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the clinical efficacy of 2 dose regimens of FGT1 in reducing peri-operative bleeding in patients undergoing revision THA.;Secondary Objective: The secondary objectives of the study are:<br>To assess the clinical efficacy of 2 dose regimens of FGT1 in reducing transfusion needs,<br>To assess the safety of 2 dose regimens of FGT1 in patients undergoing revision THA.<br>;Primary end point(s): The primary endpoint of this study is the calculated volume of peri-operative blood loss.