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

Primary Purpose

Hip Replacement, Total

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
A
B
C
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Replacement, Total focused on measuring total hip replacement, tranexamic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Txagorritxu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm 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.

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

Outcomes

Primary Outcome Measures

blood loss (ml)
blood loss 8 hours (ml)
blood loss 24 hours (ml)

Secondary Outcome Measures

Full Information

First Posted
September 7, 2010
Last Updated
February 6, 2013
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT01199627
Brief Title
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Replacement, Total
Keywords
total hip replacement, tranexamic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
Experimental
Arm 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.
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
A
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
B
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
C
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood loss (ml)
Time Frame
4 hours
Title
blood loss 8 hours (ml)
Time Frame
8 hours
Title
blood loss 24 hours (ml)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borja Barrachina, MD
Organizational Affiliation
Osakidetza-Basque Country Health Service
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cesar Valero, MD
Organizational Affiliation
Osakidetza-Basque Country Health Service
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amanda Lopez, pharmacist
Organizational Affiliation
Osakidetza-Basque Country Health Service
Official's Role
Study Chair
Facility Information:
Facility Name
Txagorritxu Hospital
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain

12. IPD Sharing Statement

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

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