Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery

Phase 3

Completed

• Conditions: Hip Replacement, Total
• Interventions: Drug: A; Drug: B; Drug: C

• Registration Number: NCT01199627
• Lead Sponsor: Basque Health Service

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2011-03
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	A	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.
B	B	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.
C	C	Placebo

Primary Outcome Measures

Name	Time	Method
blood loss (ml)	4 hours
blood loss 8 hours (ml)	8 hours
blood loss 24 hours (ml)	24 hours

Trial Locations

Locations (1)

Txagorritxu Hospital; 🇪🇸 Vitoria-Gasteiz, Alava, Spain