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The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

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ClinicalTrials.gov Identifier: NCT00697385
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Mary M. Gooley Hemophilia Center

Brief Summary:
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 or disease Intervention/treatment
vonWillebrand Disease Hemophilia Platelet Coagulation Disorders Drug: Cyclokapron

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2003
Primary Completion Date : June 2008
Study Completion Date : June 2008


Arm Intervention/treatment
Experimental: TA
on treatment
Drug: Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours
Other Name: tranexamic Acid



Primary Outcome Measures :
  1. Reduced pictorial blood assessment chart scores from baseline [ Time Frame: 3 and 6 months after start of medication ]

Secondary Outcome Measures :
  1. increased hematocrit [ Time Frame: 3 and 6 months from start of medication ]


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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT00697385


Locations
United States, New York
Mary M. Gooley Hemophilia Center
Rochester, New York, United States, 14621
Sponsors and Collaborators
Mary M. Gooley Hemophilia Center
Investigators
Principal Investigator: Peter A Kouides, MD Mary M. Gooley Hemophilia Center

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
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Disease
Von Willebrand Diseases
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Coagulation Protein Disorders
Blood Platelet Disorders
Genetic Diseases, Inborn
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants