TRANEXTOP: Tranexamic Acid for Unilateral Total Knee Arthroplasty

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Completed

CT.gov ID

NCT01594671

Collaborator

(none)

150

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss	Drug: Tranexamic Acid Drug: Tranexamic Acid Other: haemostasia	Phase 3

Detailed Description

Objectives:

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.
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:

Plasmatic concentrations of tranexamic acid
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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Amchafibrin Other: haemostasia The surgical habitual haemostasia: electrocoagulation of the bleeding tissues

Arm

Intervention/Treatment

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 Names:

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 Names:

Amchafibrin

Other: haemostasia

The surgical habitual haemostasia: electrocoagulation of the bleeding tissues

Outcome Measures

Primary Outcome Measures

Total blood loss (mL) [at 24 hours postoperatively]
Blood will be collected by drainages during the first 24 hours after surgery.

Secondary Outcome Measures

Hidden blood loss [From admission to hospital until an average of 5 days postoperative period]
Hidden blood loss will be calculated by Nadler's formula
Wound complications [5 weeks postoperatively]
We will quantify infections, haematomas and other complications related with surgery
Adverse effect related with the interventions [5 weeks postoperatively]
Any adverse effects related with tranexamic acid will be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Esperanza	Barcelona		Spain	08024
2	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025

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