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

This study has been completed.
Sponsor:
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01199627
First received: September 7, 2010
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Hip Replacement, Total
Drug: A
Drug: B
Drug: C
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • blood loss (ml) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • blood loss 8 hours (ml) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • blood loss 24 hours (ml) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199627

Locations
Spain
Txagorritxu Hospital
Vitoria-Gasteiz, Alava, Spain, 01009
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Francisco Borja Barrachina Larraza, Basque Health Service
ClinicalTrials.gov Identifier: NCT01199627     History of Changes
Other Study ID Numbers: TXA-CRT
Study First Received: September 7, 2010
Last Updated: February 6, 2013
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee

Keywords provided by Basque Health Service:
total hip replacement
tranexamic acid

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014