A Phase 3 interventional study of Tranexamic Acid and Tranexamic Acid in Blood Loss, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-19.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 3, Interventional, and Diagnostic
Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.
Objectives:
Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.
Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".
Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).
Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.
Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage 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:
Intravenous Tranexamic Acid Two dosage Tranexamic acid 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
Drug: Tranexamic Acid · Other: haemostasia
The surgical habitual haemostasia.
Other: haemostasia
Topical Tranexamic acid one dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
Drug: Tranexamic Acid · Other: haemostasia
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
One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
Also known as: Amchafibrin
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Total blood loss (mL)
Blood will be collected by drainages during the first 24 hours after surgery.
Time frame: at 24 hours postoperatively
Hidden blood loss
Hidden blood loss will be calculated by Nadler's formula
Time frame: From admission to hospital until an average of 5 days postoperative period
Wound complications
We will quantify infections, haematomas and other complications related with surgery
Time frame: 5 weeks postoperatively
Adverse effect related with the interventions
Any adverse effects related with tranexamic acid will be collected
Time frame: 5 weeks postoperatively
This study is completed, as verified in Dec 2012. 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