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

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.

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 Overview

• Status: Completed
• Conditions: Knee Arthropathy
• Intervention / Treatment: Drug: Tranexamic Acid; Biological: Fibrin glue; Drug: Fibrin glue; Other: Habitual haemostasis

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Barcelona, Catalunya, Spain, 08025
      • Hospital de La Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; 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; 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
Experimental: Fibrin glue BSTC; It is homologous fibrin glue from a single blood donor.	Biological: Fibrin glue; Topical administration, before to close the surgical wound.
Experimental: Tissucol; It is fibrin glue commercialized from multiple donors.	Drug: Fibrin glue; Topical administration, before to close the surgical wound. Dosage: 2 mL.; Other Names: Tissucol
Other: Habitual haemostasis; Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis)	Other: Habitual haemostasis; The surgical habitual haemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative blood loss (mL)	Blood loss (mL) by the surgical wound collected by drain systems.	During the first 48h after the surgical intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Pain of surgical wound	During the first postoperative week
Units of blood transfusion	During the first postoperative week
hospital length stay	Days
Mortality	During the first postoperative month

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Banc de Sang i Teixits
• Investigators: Study Director: Martinez Zapata, Mª José, Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau; Principal Investigator: Aguilera Roig, Xavier, Hospital de la Santa Creu i Sant Pau. IIB Sant Pau

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: primary knee arthroplasty; tranexamic acid; fibrin glue; topic
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Coagulants; Fibrin Tissue Adhesive; Hemostatics; Tranexamic Acid
• Other Study ID Numbers: 2009-017804-95; TRA-81 (Other Grant/Funding Number: Spanish Health Ministry and Social Policy)