Tranexamic Acid for Unilateral Total Knee Arthroplasty (TRANEXTOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01594671
First received: May 3, 2012
Last updated: December 18, 2012
Last verified: December 2012

May 3, 2012
December 18, 2012
February 2012
October 2012   (final data collection date for primary outcome measure)
Total blood loss (mL) [ Time Frame: at 24 hours postoperatively ] [ Designated as safety issue: No ]
Blood will be collected by drainages during the first 24 hours after surgery.
Same as current
Complete list of historical versions of study NCT01594671 on ClinicalTrials.gov Archive Site
  • Hidden blood loss [ Time Frame: From admission to hospital until an average of 5 days postoperative period ] [ Designated as safety issue: No ]
    Hidden blood loss will be calculated by Nadler's formula
  • Wound complications [ Time Frame: 5 weeks postoperatively ] [ Designated as safety issue: Yes ]
    We will quantify infections, haematomas and other complications related with surgery
  • Adverse effect related with the interventions [ Time Frame: 5 weeks postoperatively ] [ Designated as safety issue: Yes ]
    Any adverse effects related with tranexamic acid will be collected
  • Hidden blodd loss [ Time Frame: From admission to hospital until an average of 5 days postoperative period ] [ Designated as safety issue: No ]
    Hidden blood loss will be calculated by Nadler's formula
  • Wound complications [ Time Frame: 5 weeks postoperatively ] [ Designated as safety issue: Yes ]
    We will quantifie infections, haematomas and another complications related with surgery
  • Adverse effect relationated with the interventions [ Time Frame: 5 weeks postoperatively ] [ Designated as safety issue: Yes ]
    Any adverse effects relationated with tranexamic acid will be collected
Not Provided
Not Provided
 
Tranexamic Acid for Unilateral Total Knee Arthroplasty
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.

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Blood Loss
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01594671
IIBSP-ATR-2010-23
No
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
December 2012

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