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Randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in patients with hip fracture

Phase 1
Conditions
Hip fracture.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Registration Number
EUCTR2020-002144-23-ES
Lead Sponsor
Asociación Instituto Biodonostia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
644
Inclusion Criteria

- Who is over 65 years of age, of both sexes.
- Accept participation in the study (informed consent that will be signed by the patient or family member / legal representative depending on the degree of autonomy of the patient).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 644

Exclusion Criteria

- In treatment with another experimental drug (not participating in another clinical trial with an experimental drug).
- The refusal of the patient to participate in the study.
- Known allergy to TXA.
- Patients with a history of seizures.
- Patients with severe kidney and liver failure.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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