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

Mary M. Gooley Hemophilia Center13 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

vonWillebrand Disease Hemophilia Platelet Coagulation Disorders

Eligibility

Sex: FEMALEMin age: 8 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduced pictorial blood assessment chart scores from baseline

Time frame: 3 and 6 months after start of medication

Secondary Outcomes

increased hematocrit

Time frame: 3 and 6 months from start of medication