Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.
- Conditions
- Patient with a hip fracture and a prosthesis is needed.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-006278-15-ES
- Lead Sponsor
- Institut de Recerca Hospital de la Sant Creu i Sant Pau
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Patients older than 18 years
-Patients with unilateral subcapital femoral fracture
-Patients requiring hip replacement (total or partial)
-Signature of informed consent from the patient or their legal representative
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
-Multiple fractures
-That the patient did not give informed consent or their legal
-Known allergy-fibrin glue or tranexamic acid
-Background compatible with thromboembolic disease:
? cerebrovascular accident
? Coronary heart disease (myocardial infarction, angina)
? Deep vein thrombosis
? Pulmonary embolism
? peripheral arterial vascular disease
? Patients with thrombogenic arrhythmias
? Patients with prosthetic heart
? Coagulation disorders prothrombotic
-Contraceptives, or estrogen therapy
- Use of recuperators blood during surgery
-Treatment with iron-on post-operative
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method