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Last Updated: May 17, 2022

CLINICAL TRIALS PROFILE FOR CYKLOKAPRON


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505(b)(2) Clinical Trials for Cyklokapron

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 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 Cyklokapron

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.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed Canadian Hemophilia Society Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed K. Sue Robinson Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed Nova Scotia Health Authority Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00985920 ↗ Topical Tranexamic Acid for Total Knee Arthroplasty Completed The Physicians' Services Incorporated Foundation Phase 4 2007-09-01 Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed study is to determine the role of topical application of tranexamic acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal drop in hemoglobin concentration following surgery. This proposal describes a randomized, double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include transfusion requirements, hospital stay, joint functionality, quality of life and safety of using topical TA. Topical application of TA is a novel intraoperative approach that has not been used or studied in TKA. However if it is effective, it will directly reduce postoperative intra-articular bleeding without subsequent systemic absorption and thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will lead to less pain and infection rates as well as improved surgical functional outcomes.
NCT00985920 ↗ Topical Tranexamic Acid for Total Knee Arthroplasty Completed University Health Network, Toronto Phase 4 2007-09-01 Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed study is to determine the role of topical application of tranexamic acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal drop in hemoglobin concentration following surgery. This proposal describes a randomized, double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include transfusion requirements, hospital stay, joint functionality, quality of life and safety of using topical TA. Topical application of TA is a novel intraoperative approach that has not been used or studied in TKA. However if it is effective, it will directly reduce postoperative intra-articular bleeding without subsequent systemic absorption and thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will lead to less pain and infection rates as well as improved surgical functional outcomes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyklokapron

Condition Name

Condition Name for Cyklokapron
Intervention Trials
Surgical Blood Loss 3
Osteoarthritis 3
Hip Fractures 3
Wounds and Injuries 2
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Condition MeSH

Condition MeSH for Cyklokapron
Intervention Trials
Hemorrhage 17
Blood Loss, Surgical 5
Postoperative Hemorrhage 5
Hematoma 5
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Clinical Trial Locations for Cyklokapron

Trials by Country

Trials by Country for Cyklokapron
Location Trials
United States 39
Canada 20
Australia 7
Netherlands 2
China 2
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Trials by US State

Trials by US State for Cyklokapron
Location Trials
Minnesota 4
Texas 4
California 3
Ohio 3
South Carolina 2
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Clinical Trial Progress for Cyklokapron

Clinical Trial Phase

Clinical Trial Phase for Cyklokapron
Clinical Trial Phase Trials
Phase 4 17
Phase 3 12
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Cyklokapron
Clinical Trial Phase Trials
Completed 23
Recruiting 15
Unknown status 4
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Clinical Trial Sponsors for Cyklokapron

Sponsor Name

Sponsor Name for Cyklokapron
Sponsor Trials
Population Health Research Institute 4
Sunnybrook Health Sciences Centre 3
University Health Network, Toronto 3
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Sponsor Type

Sponsor Type for Cyklokapron
Sponsor Trials
Other 85
U.S. Fed 5
Industry 4
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