Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

Knee Arthropathy Clinical Trial

— ATRHEMOS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306370
• Other study ID #: 2009-017804-95
• Secondary ID: TRA-81
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2011
• Last updated: August 27, 2013
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Arthropathy

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Banc de Sang i Teixits

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative blood loss (mL)	Blood loss (mL) by the surgical wound collected by drain systems.	During the first 48h after the surgical intervention	No
Secondary	Percentage of patients that need a postoperative blood transfusion		During the first postoperative week	No
Secondary	Percentage of patients with surgical wound infection		During the first postoperative month	Yes
Secondary	Percentage of patients with surgical wound dehiscence		During the first postoperative month	Yes
Secondary	Percentage of patients with re-intervention by wound complications		During the first postoperative month	Yes
Secondary	Incidence of deep venous thrombosis		During the first postoperative week	Yes
Secondary	Pain of surgical wound		During the first postoperative week	Yes
Secondary	Units of blood transfusion		During the first postoperative week	Yes
Secondary	hospital length stay		Days	No
Secondary	Mortality		During the first postoperative month	Yes