Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty (ATRHEMOS)
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|ClinicalTrials.gov Identifier: NCT01306370|
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : August 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Knee Arthropathy||Drug: Tranexamic Acid Drug: Fibrin glue Biological: Fibrin glue Other: Habitual haemostasis||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||November 2011|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|