Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery (TRA)
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|ClinicalTrials.gov Identifier: NCT03386656|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Amchafibrin Other: Saline Solution||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||November 28, 2017|
|Actual Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Estimated total blood loss, measured using the formula described by Nadler. A difference in estimated blood loss greater than or equal to 245 ml will be considered clinically relevant.
Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Placebo Comparator: Saline Solution 0,9%.
Comparator of tranexamic acid
Other: Saline Solution
Other Name: Placebo
- Saving blood loss in knee surgery [ Time Frame: 24 hours post-intervention ]Total blood loss greater than 245 ml
- Time post-intervention of functional recovery in study subjects [ Time Frame: Four weeks post-discharger ]
- Length of hospital stay in study subjects [ Time Frame: Four weeks post-discharger ]
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): NCT03386656
|Hospital Universitario Puerta del Mar|
|Cadiz, Spain, 11009|