TRANEXAMIC ACID for Hip fracture

Inclusion criteria

• {"criterion_text":"- Who is over 65 years of age, of both sexes.\n- 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)."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Blood transfusion The first result of this study will be the transfusion rate from patient admission to hospital discharge. Patients will be monitored with serial measurements of hemoglobin and hematocrit levels, as well as vital signs and symptoms to assess the need for transfusion.","definition_or_measurement_approach":"Transfusion rate from patient admission to hospital discharge; patients monitored with serial measurements of hemoglobin and hematocrit levels and vital signs/symptoms to assess need for transfusion."}

Secondary endpoints

• {"endpoint_text":"- Hb level: Hb admission, (day 0) Hb day 1, Hb day 2, Hb day 3, Hb preQ, Hb postQ1, Hb postQ2, Hb postQ3","definition_or_measurement_approach":"Serial hemoglobin measurements at specified time points (admission, day 0, day 1, day 2, day 3, pre-operative, and post-operative timepoints postQ1-postQ3)."}
• {"endpoint_text":"- Hto level","definition_or_measurement_approach":"Measurement of haematocrit level at study-specified timepoints."}
• {"endpoint_text":"- Occult blood loss: from fracture to admission, and from admission to surgery","definition_or_measurement_approach":"Calculated/assessed occult blood loss during specified intervals (fracture to admission; admission to surgery)."}
• {"endpoint_text":"- Total loss of blood.","definition_or_measurement_approach":"Assessment of total blood loss (methodology not further specified in the record)."}
• {"endpoint_text":". - Adverse events during hospital admission and 3-6-9-12 months postopitalar: DVT, PE, CVA, heart attack, wound infection, urinary infection, respiratory infection, dementia / delirium, wound hematoma-seroma, readmission , reoperation, transfusion reaction, death.","definition_or_measurement_approach":"Recording of specified adverse events during hospital admission and at 3, 6, 9 and 12 months postoperatively."}
• {"endpoint_text":". - Charlson comorbidities index.","definition_or_measurement_approach":"Charlson comorbidity index score assessment."}
• {"endpoint_text":"- ASA","definition_or_measurement_approach":"ASA (American Society of Anesthesiologists) classification assessment."}
• {"endpoint_text":"- Tto. with anticoagulant, antiplatelet medication.","definition_or_measurement_approach":"Recording of anticoagulant and antiplatelet medication use."}
• {"endpoint_text":"- Epidemiological data: age, sex, weight, height.","definition_or_measurement_approach":"Collection of standard demographic and anthropometric data."}
• {"endpoint_text":"- Time from trauma to hospital admission (in hours).","definition_or_measurement_approach":"Measurement in hours from time of trauma to hospital admission."}
• {"endpoint_text":"- Previous functionality.","definition_or_measurement_approach":"Assessment of pre-fracture functional status (method not specified)."}
• {"endpoint_text":"- Date of admission.","definition_or_measurement_approach":"Recording of hospital admission date."}
• {"endpoint_text":"- Date of surgical intervention.","definition_or_measurement_approach":"Recording of date of surgery."}
• {"endpoint_text":"- Date of hospital discharge","definition_or_measurement_approach":"Recording of discharge date."}
• {"endpoint_text":"- Hospital stay","definition_or_measurement_approach":"Duration of hospital stay (days)."}
• {"endpoint_text":"- Type of fracture.","definition_or_measurement_approach":"Classification/recording of fracture type."}
• {"endpoint_text":"- Type of surgical intervention.","definition_or_measurement_approach":"Recording of surgical intervention type."}
• {"endpoint_text":"- Functionality per year.","definition_or_measurement_approach":"Assessment of functional outcome at one year."}

Spain

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

14-03-2025

Processing Time Days

127

Number Of Sites

2

Number Of Participants

644

Primary sponsor

Full Name

Asociacion Instituto Biogipuzkoa

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain