Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery (TXA-CRT)

Basque Health Service

Status and phase: Completed; Phase 3

Conditions: Hip Replacement, Total

Treatments: Drug: C; Drug: B; Drug: A

Study type: Interventional

Funder types: Other

Identifiers

NCT01199627

TXA-CRT

Details and patient eligibility

About

The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.

PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.

Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.

Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.

2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or more
• ASA I-III
• No allergies tranexamic acid
• Informed consent signed by patient

Exclusion criteria

• Pregnancy or lactation.
• severe vascular ischemia (coronary or peripheral)
• previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)
• coagulopathy
• Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension
• Hemoglobine <10
• moderate renal impairment (creatinine> 2)
• Cirrhosis
• contraindication to prophylaxis with enoxaparin
• Patients with a history of seizures.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.

Treatment:

Drug: A

B

Experimental group

Description:

Group B: 1st dose: 10mg/kg of TXA (tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.

Treatment:

Drug: B

C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: C