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

September 7, 2010
February 6, 2013
March 2011
February 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01199627 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Hip Replacement, Total
  • 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.

  • 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.

  • 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.

  • 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.

    Intervention: Drug: A
  • 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.

    Intervention: Drug: B
  • Placebo Comparator: C
    Placebo
    Intervention: Drug: C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01199627
TXA-CRT
No
Francisco Borja Barrachina Larraza, Basque Health Service
Basque Health Service
Not Provided
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
Basque Health Service
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP