Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03386656
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-06-26
Brief Title:
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
Sponsor:
Fundación Pública Andaluza Progreso y Salud
Organization:
Andalusian Network for Design and Translation of Advanced Therapies
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRA
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None