Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

NCT01306370 | Completed Phase 3

• 2 other identifiers: 2009-017804-95TRA-81
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

primary knee arthroplasty; fibrin glue; tranexamic acid; topic

Outcome Measures

Primary Outcomes (1)

• Postoperative blood loss (mL)

  Blood loss (mL) by the surgical wound collected by drain systems.

  During the first 48h after the surgical intervention

Secondary Outcomes (9)

• Percentage of patients that need a postoperative blood transfusion

  During the first postoperative week

• Percentage of patients with surgical wound infection

  During the first postoperative month

• Percentage of patients with surgical wound dehiscence

  During the first postoperative month

• Percentage of patients with re-intervention by wound complications

  During the first postoperative month

• Incidence of deep venous thrombosis

  During the first postoperative week

Study Arms (4)

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.

Drug: Tranexamic Acid

Fibrin glue BSTC

EXPERIMENTAL

It is homologous fibrin glue from a single blood donor.

Biological: Fibrin glue

Tissucol

EXPERIMENTAL

It is fibrin glue commercialized from multiple donors.

Drug: Fibrin glue

Habitual haemostasis

OTHER

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

Other: Habitual haemostasis

Interventions

Tranexamic Acid DRUG

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

Also known as: Amchafibrin

Tranexamic acid

Fibrin glue DRUG

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

Also known as: Tissucol

Tissucol

Habitual haemostasis OTHER

The surgical habitual haemostasis.

Habitual haemostasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total knee arthroplasty
• The patient consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Banc de Sang i Teixits: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

MeSH Terms

Interventions

Tranexamic Acid; Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Martinez Zapata, Mª José

  Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau

  STUDY DIRECTOR

• Aguilera Roig, Xavier

  Hospital de la Santa Creu i Sant Pau. IIB Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

ES (1)