Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty (ATRHEMOS)

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

Status and phase: Completed; Phase 3

Conditions: Knee Arthropathy

Treatments: Other: Habitual haemostasis; Biological: Fibrin glue; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01306370

TRA-81 (Other Grant/Funding Number)

2009-017804-95

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

172 participants in 4 patient groups

Tranexamic acid

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Fibrin glue BSTC

Experimental group

Description:

It is homologous fibrin glue from a single blood donor.

Treatment:

Biological: Fibrin glue

Biological: Fibrin glue

Tissucol

Experimental group

Description:

It is fibrin glue commercialized from multiple donors.

Habitual haemostasis

Other group

Description:

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

Treatment:

Other: Habitual haemostasis