Trial | NCT01306370  Report issue

Title

Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    172
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.
Study Started
Jun 30
2010
Primary Completion
Oct 31
2011
Study Completion
Nov 30
2011
Last Update
Aug 28
2013
Estimate

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

Drug Fibrin glue

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

  • Other names: Tissucol

Biological Fibrin glue

Topical administration, before to close the surgical wound.

Other Habitual haemostasis

The surgical habitual haemostasis.

Tranexamic acid Experimental

Tranexamic acid is a synthetic derivative of the amino acid lysine. It inhibits fibrinolysis by blocking the lysine binding sites on plasminogen and facilitates the coagulation process.

Fibrin glue BSTC Experimental

It is homologous fibrin glue from a single blood donor.

Tissucol Experimental

It is fibrin glue commercialized from multiple donors.

Habitual haemostasis Other

Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis)

Criteria 

Inclusion Criteria:

Total knee arthroplasty
The patient consent to participate

Exclusion Criteria:

Intolerance drugs to the study or to bovine protein (aprotinin)
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
No Results Posted