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

Hip Replacement, Total Clinical Trial

— TXA-CRT  

Official title:

Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199627
• Other study ID #: TXA-CRT
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2010
• Last updated: February 6, 2013
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hip Replacement, Total

Intervention

Drug:
• 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
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
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.

Locations

Country	Name	City	State
Spain	Txagorritxu Hospital	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss (ml)		4 hours	No
Primary	blood loss 8 hours (ml)		8 hours	No
Primary	blood loss 24 hours (ml)		24 hours	No