The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
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Purpose
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.
| Condition | Intervention |
|---|---|
|
vonWillebrand Disease Hemophilia Platelet Coagulation Disorders |
Drug: Cyclokapron |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders |
- Reduced pictorial blood assessment chart scores from baseline [ Time Frame: 3 and 6 months after start of medication ] [ Designated as safety issue: No ]
- increased hematocrit [ Time Frame: 3 and 6 months from start of medication ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | April 2003 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TA
on treatment
|
Drug: Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours
Other Name: tranexamic Acid
|
Detailed Description:
Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.
Eligibility| Ages Eligible for Study: | 8 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- all menstruating women regardless of age
- Women with heavy periods as measured by pictorial blood assessment chart
- Women diagnosed with a bleeding disorder
Exclusion Criteria:
- Acquired defective color vision
- Factor VIII, Factor IX, FactorXI levels >250%
- An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
- Current use of oral contraceptives
Contacts and Locations| United States, New York | |
| Mary M. Gooley Hemophilia Center | |
| Rochester, New York, United States, 14621 | |
| Principal Investigator: | Peter A Kouides, MD | Mary M. Gooley Hemophilia Center |
More Information
No publications provided
| Responsible Party: | Peter A. kouides, M.D., Mary M. Gooley Hemophilia Center |
| ClinicalTrials.gov Identifier: | NCT00697385 History of Changes |
| Other Study ID Numbers: | 758-A-03-1 |
| Study First Received: | June 10, 2008 |
| Last Updated: | September 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia A Hemorrhage Hematologic Diseases Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn |
Pathologic Processes Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013