Hip Fractures
Conditions
Keywords
Hip Fracture, Blood loss, tranexamic acid
Brief summary
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality. Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis. It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Detailed description
Prevention and treatment of bleeding due to general or local fibrinolysis
Interventions
DRUGTranexamic acid
Intravenous or topical administration
OTHERPhysiologic saline
Placebo
Sponsors
Biogipuzkoa Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture * Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
Exclusion criteria
* Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug). * The refusal of the patient or their relatives/legal representative to participate in the study. * Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients). * Patients with a history of seizures. * Patients with severe renal and hepatic insufficiency. * Patients with venous thrombosis. * Patients with active concomitant bleeding of renal origin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. | Transfusion rate from patient admission to hospital discharge. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | 3,6,9 and 12 months |
| Days at hospital | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. |
| Total blood loss | From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation. |
Countries
Spain
Outcome results
None listed