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

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

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

Study Overview

• Status: Completed
• Conditions: Hip Replacement, Total
• Intervention / Treatment: Drug: A; Drug: B; Drug: C

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Txagorritxu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Drug: 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.
Placebo Comparator: C; Placebo	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood loss (ml)	4 hours
blood loss 8 hours (ml)	8 hours
blood loss 24 hours (ml)	24 hours

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Borja Barrachina, MD, Osakidetza-Basque Country Health Service; Study Chair: Cesar Valero, MD, Osakidetza-Basque Country Health Service; Study Chair: Amanda Lopez, pharmacist, Osakidetza-Basque Country Health Service

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 7, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: total hip replacement; tranexamic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TXA-CRT