Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2012-02-29
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
2. Secondary: To assess the treatment safety. To perform a cost- analyses.
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:
1. Plasmatic concentrations of tranexamic acid
2. In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tranexamic acid
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
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
haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Habitual haemostasia
The surgical habitual haemostasia.
haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Topical Tranexamic acid
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.
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.
haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
haemostasia
The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient consent to participate
Exclusion Criteria
* Patient with cardiac alterations of the rhythm
* Patients with valvular cardiac prosthesis
* Patients with pro-thrombotic alterations of coagulation
* Treatment with anticonceptive drugs
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aguilera X, M.D
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Martinez-Zapata MJ, PhD
Role: STUDY_DIRECTOR
Centro Cochrane Iberoamericano. IIB Sant Pau
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de la Esperanza
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIBSP-ATR-2010-23
Identifier Type: -
Identifier Source: org_study_id