Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
NCT Number: NCT03386656
To compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).
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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Cadiz, 11009, Spain
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is transformed into plasmin. The activity of the tranexamic acid-plasmin complex on fibrin activity is less than the activity of free plasmin alone.
There are two methods of presentation: one, as an injectable solution; Two as a clear, colorless aqueous solution.
Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due to general fibrinolysis. As for its specific indications the investigators find that it is used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological, thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the administration of a fibrinolytic drug.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Placebo
Other names: Placebo
Time frame: 24 hours post-intervention
Total blood loss greater than 245 ml
Time frame: Four weeks post-discharger
Time frame: Four weeks post-discharger
Fundación Pública Andaluza Progreso y Salud
Other
Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
Acronym: TRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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