Clinical trial NCT01594671: Tranexamic Acid for Unilateral Total Knee Arthroplasty
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss
Keywords: primary knee arthroplasty
tranexamic acid
topical
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Total blood loss (mL)
timeFrame: at 24 hours postoperatively
Secondary outcomes:
measure: Hidden blood loss
timeFrame: From admission to hospital until an average of 5 days postoperative period
measure: Wound complications
timeFrame: 5 weeks postoperatively
measure: Adverse effect related with the interventions
timeFrame: 5 weeks postoperatively
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Esperanza
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Aguilera X, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Cochrane Iberoamericano. IIB Sant Pau
name: Martinez-Zapata MJ, PhD
role: STUDY_DIRECTOR
References: