Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty (ATRHEMOS)
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.
|Knee Arthropathy||Drug: Tranexamic Acid Drug: Fibrin glue Biological: Fibrin glue Other: Habitual haemostasis||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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.|
- Postoperative blood loss (mL) [ Time Frame: During the first 48h after the surgical intervention ]Blood loss (mL) by the surgical wound collected by drain systems.
- 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 ]
|Study Start Date:||June 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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 Name: 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.
It is fibrin glue commercialized from multiple donors.
Drug: Fibrin glue
Topical administration, before to close the surgical wound. Dosage: 2 mL.
Other Name: Tissucol
Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis)
Other: Habitual haemostasis
The surgical habitual haemostasis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306370
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Catalunya, Spain, 08025|
|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|