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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Blood Loss
 Drug: Tranexamic Acid
Other: haemostasia
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 150
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 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
Other: haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Active Comparator: Habitual haemostasia
The surgical habitual haemostasia.
 Other: haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
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.
 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

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.
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594671

Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital de la Esperanza
Barcelona, Spain, 08024
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01594671     History of Changes
Other Study ID Numbers: IIBSP-ATR-2010-23
Study First Received: May 3, 2012
Last Updated: December 18, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
primary knee arthroplasty
tranexamic acid
topical

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
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 May 19, 2013