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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR TRANEXAMIC ACID


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505(b)(2) Clinical Trials for Tranexamic Acid

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT00588133 ↗ A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery Completed Mayo Clinic Phase 3 2004-01-01 Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.
OTC NCT04550338 ↗ Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure Withdrawn University of Alabama at Birmingham Phase 3 2021-08-01 A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.
New Dosage NCT05075200 ↗ Tranexamic Acid Dosing for Major Joint Replacement Surgery Not yet recruiting Sunnybrook Health Sciences Centre Phase 2 2021-10-01 Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis. The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion. Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's. This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tranexamic Acid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111215 ↗ Treatment and Management of Women With Bleeding Disorders Completed Centers for Disease Control and Prevention N/A 2001-01-01 The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
NCT00147862 ↗ Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery? Completed Tata Memorial Hospital Phase 3 2005-05-01 To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery.
NCT00279578 ↗ Clot Formation and Clot Stability in Patients With Severe Haemophilia A Completed University of Aarhus N/A 2006-01-01 In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tranexamic Acid

Condition Name

Condition Name for Tranexamic Acid
Intervention Trials
Blood Loss 30
Tranexamic Acid 27
Hemorrhage 21
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Condition MeSH

Condition MeSH for Tranexamic Acid
Intervention Trials
Hemorrhage 203
Postpartum Hemorrhage 40
Osteoarthritis 34
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Clinical Trial Locations for Tranexamic Acid

Trials by Country

Trials by Country for Tranexamic Acid
Location Trials
United States 225
Canada 68
Egypt 52
China 36
Australia 24
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Trials by US State

Trials by US State for Tranexamic Acid
Location Trials
New York 29
Pennsylvania 16
California 16
Illinois 13
Michigan 12
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Clinical Trial Progress for Tranexamic Acid

Clinical Trial Phase

Clinical Trial Phase for Tranexamic Acid
Clinical Trial Phase Trials
Phase 4 151
Phase 3 114
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Tranexamic Acid
Clinical Trial Phase Trials
Completed 208
Recruiting 92
Unknown status 86
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Clinical Trial Sponsors for Tranexamic Acid

Sponsor Name

Sponsor Name for Tranexamic Acid
Sponsor Trials
Aswan University Hospital 19
Assiut University 13
Cairo University 12
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Sponsor Type

Sponsor Type for Tranexamic Acid
Sponsor Trials
Other 633
Industry 26
NIH 8
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