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| ID | Type | Description | Link |
|---|---|---|---|
| TRA-81 | Other Grant/Funding Number | Spanish Health Ministry and Social Policy |
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| Name | Class |
|---|---|
| Banc de Sang i Teixits | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | 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. |
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| Fibrin glue BSTC | Experimental | It is homologous fibrin glue from a single blood donor. |
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| Tissucol | Experimental | It is fibrin glue commercialized from multiple donors. |
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| Habitual haemostasis | Other | Electrocoagulation of blood vessels was performed during surgery in all patients (routine hemostasis) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative blood loss (mL) | Blood loss (mL) by the surgical wound collected by drain systems. | During the first 48h after the surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients that need a postoperative blood transfusion | During the first postoperative week | |
| Percentage of patients with surgical wound infection | During the first postoperative month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martinez Zapata, Mª José | Centro Cochrane Iberoamericano. Servicio de EpidemiologÃa ClÃnica y Salud Pública. IIB Sant Pau | Study Director |
| Aguilera Roig, Xavier | Hospital de la Santa Creu i Sant Pau. IIB Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Fibrin glue | Drug | Topical administration, before to close the surgical wound. Dosage: 2 mL. |
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| Fibrin glue | Biological | Topical administration, before to close the surgical wound. |
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| Habitual haemostasis | Other | The surgical habitual haemostasis. |
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| Percentage of patients with surgical wound dehiscence | During the first postoperative month |
| Percentage of patients with re-intervention by wound complications | During the first postoperative month |
| Incidence of deep venous thrombosis | During the first postoperative week |
| Pain of surgical wound | During the first postoperative week |
| Units of blood transfusion | During the first postoperative week |
| hospital length stay | Days |
| Mortality | During the first postoperative month |
| D005337 |
| Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |