A Phase 3 interventional study of Tranexamic Acid and Fibrin glue in Knee Arthropathy, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-28.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 3, Interventional, and Prevention
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 172 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
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
It is homologous fibrin glue from a single blood donor.
Biological: Fibrin glue
It is fibrin glue commercialized from multiple donors.
Drug: Fibrin glue
Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis)
Other: Habitual haemostasis
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
Topical administration, before to close the surgical wound. Dosage: 2 mL.
Also known as: Tissucol
Topical administration, before to close the surgical wound.
The surgical habitual haemostasis.
Postoperative blood loss (mL)
Blood loss (mL) by the surgical wound collected by drain systems.
Time frame: During the first 48h after the surgical intervention
Percentage of patients that need a postoperative blood transfusion
Time frame: During the first postoperative week
Percentage of patients with surgical wound infection
Time frame: During the first postoperative month
Percentage of patients with surgical wound dehiscence
Time frame: During the first postoperative month
Percentage of patients with re-intervention by wound complications
Time frame: During the first postoperative month
Incidence of deep venous thrombosis
Time frame: During the first postoperative week
Pain of surgical wound
Time frame: During the first postoperative week
Units of blood transfusion
Time frame: During the first postoperative week
hospital length stay
Time frame: Days
Mortality
Time frame: During the first postoperative month
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau