Clinical trial NCT01306370: Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Arthropathy
Keywords: primary knee arthroplasty
fibrin glue
tranexamic acid
topic
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Banc de Sang i Teixits
First posted: 2011-03-01
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Postoperative blood loss (mL)
timeFrame: During the first 48h after the surgical intervention
Secondary outcomes:
measure: Percentage of patients that need a postoperative blood transfusion
timeFrame: During the first postoperative week
measure: Percentage of patients with surgical wound infection
timeFrame: During the first postoperative month
measure: Percentage of patients with surgical wound dehiscence
timeFrame: During the first postoperative month
measure: Percentage of patients with re-intervention by wound complications
timeFrame: During the first postoperative month
measure: Incidence of deep venous thrombosis
timeFrame: During the first postoperative week
measure: Pain of surgical wound
timeFrame: During the first postoperative week
measure: Units of blood transfusion
timeFrame: During the first postoperative week
measure: hospital length stay
timeFrame: Days
measure: Mortality
timeFrame: During the first postoperative month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya
Study officials:
affiliation: Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
name: Martinez Zapata, Mª José
role: STUDY_DIRECTOR
affiliation: Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
name: Aguilera Roig, Xavier
role: PRINCIPAL_INVESTIGATOR
References: