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Tranexamic Acid for Unilateral Total Knee Arthroplasty (TRANEXTOP)

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ClinicalTrials.gov Identifier: NCT01594671
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date December 19, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Total blood loss (mL) [ Time Frame: at 24 hours postoperatively ]
Blood will be collected by drainages during the first 24 hours after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • Hidden blood loss [ Time Frame: From admission to hospital until an average of 5 days postoperative period ]
    Hidden blood loss will be calculated by Nadler's formula
  • Wound complications [ Time Frame: 5 weeks postoperatively ]
    We will quantify infections, haematomas and other complications related with surgery
  • Adverse effect related with the interventions [ Time Frame: 5 weeks postoperatively ]
    Any adverse effects related with tranexamic acid will be collected
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • Hidden blodd loss [ Time Frame: From admission to hospital until an average of 5 days postoperative period ]
    Hidden blood loss will be calculated by Nadler's formula
  • Wound complications [ Time Frame: 5 weeks postoperatively ]
    We will quantifie infections, haematomas and another complications related with surgery
  • Adverse effect relationated with the interventions [ Time Frame: 5 weeks postoperatively ]
    Any adverse effects relationated with tranexamic acid will be collected
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tranexamic Acid for Unilateral Total Knee Arthroplasty
Official Title  ICMJE Prevention of Postoperative Blood Loss: Randomised Multicentre Parallel Clinical Trial That Assess the Topical and Intravenous Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.
Brief Summary Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.
Detailed Description

Objectives:

  1. Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
  2. Secondary: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.

Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".

Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).

Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.

Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:

  1. Plasmatic concentrations of tranexamic acid
  2. In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Blood Loss
Intervention  ICMJE
  • Drug: Tranexamic Acid

    Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.

    Each dosage: 2 ampoules of 500mg/5 mL/ampoule

    Other Name: Amchafibrin
  • Drug: Tranexamic Acid
    One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
    Other Name: Amchafibrin
  • Other: haemostasia
    The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Study Arms  ICMJE
  • Experimental: Tranexamic acid

    Intravenous Tranexamic Acid Two dosage Tranexamic acid during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.

    Each dosage: 2 ampoules of 500mg/5 mL/ampoule Other Name: Amchafibrin

    Interventions:
    • Drug: Tranexamic Acid
    • Other: haemostasia
  • Active Comparator: Habitual haemostasia
    The surgical habitual haemostasia.
    Intervention: Other: haemostasia
  • Experimental: Topical Tranexamic acid
    Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
    Interventions:
    • Drug: Tranexamic Acid
    • Other: haemostasia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral Total knee arthroplasty
  • The patient consent to participate

Exclusion Criteria:

  • Antecedent of thromboembolic disease
  • Patient with cardiac alterations of the rhythm
  • Patients with valvular cardiac prosthesis
  • Patients with pro-thrombotic alterations of coagulation
  • Treatment with anticonceptive drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594671
Other Study ID Numbers  ICMJE IIBSP-ATR-2010-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aguilera X, M.D Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Director: Martinez-Zapata MJ, PhD Centro Cochrane Iberoamericano. IIB Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date December 2012

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