Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
NCT ID: NCT01306370
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
172 participants
INTERVENTIONAL
2010-06-30
2011-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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 BSTC
It is homologous fibrin glue from a single blood donor.
Fibrin glue
Topical administration, before to close the surgical wound.
Tissucol
It is fibrin glue commercialized from multiple donors.
Fibrin glue
Topical administration, before to close the surgical wound. Dosage: 2 mL.
Habitual haemostasis
Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis)
Habitual haemostasis
The surgical habitual haemostasis.
Interventions
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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.
Fibrin glue
Topical administration, before to close the surgical wound.
Habitual haemostasis
The surgical habitual haemostasis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient consent to participate
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Banc de Sang i Teixits
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Martinez Zapata, Mª José
Role: STUDY_DIRECTOR
Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
Aguilera Roig, Xavier
Role: PRINCIPAL_INVESTIGATOR
Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Countries
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Other Identifiers
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TRA-81
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2009-017804-95
Identifier Type: -
Identifier Source: org_study_id