Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

Summary

Objectives:

a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.

Secondaries: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.

Nº of participant centres: 1. Random allocation will be centralised.

Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.

Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.

Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.

Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.

Conditions

• Knee Arthropathy

Interventions

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

DRUG

Fibrin glue

Topical administration, before to close the surgical wound. Dosage: 2 mL.

BIOLOGICAL

Fibrin glue

Topical administration, before to close the surgical wound.

OTHER

Habitual haemostasis

The surgical habitual haemostasis.

Sponsors & Collaborators

• Banc de Sang i Teixits

  collaborator OTHER

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Principal Investigators

• Martinez Zapata, Mª José · Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau

• Aguilera Roig, Xavier · Hospital de la Santa Creu i Sant Pau. IIB Sant Pau

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2011-10-31

Completion

2011-11-30

Countries

• Spain

Study Locations