Status:
UNKNOWN
Evaluation of Menses in Congenital Bleeding Disorders
Lead Sponsor:
University of L'Aquila
Conditions:
Von Willebrand Disease
Congenital Coagulation Factors Deficiency
Eligibility:
FEMALE
18-45 years
Brief Summary
Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed ...
Detailed Description
The following is a multicentric, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women affected by Congenital Blee...
Eligibility Criteria
Inclusion
- Age between 18 and 45 years;
- Ascertained diagnosis of one of the following inherited bleeding disorders:
- Von Willebrand Disease type 1, 2, 3 severe and moderate (VWF:RCo \< 30 %),as diagnosed following Italian guidelines \[4\]
- Glanzmann Thromboasthenia
- Congenital Coagulation Factor VII, II or X deficiency
- A and B Haemophilia Carriers (Factor VIII and IX \<25%);
- Bleeding Severity score \> 2
- Signing the consent form.
Exclusion
- 1\. Under continuous anti-hemorrhagic prophylaxis 2. Affected by an active cancer or anti-phospholipid antibodies syndrome 3. History of liver, kidney or endocrine disorders 4. Submucous uterine fibroids, uterine polyps or malignancy 5. Use of oral contraceptives or intrauterine devices in the past three months 6. Treatment with non-steroidal anti-inflammatory drugs
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Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01261936
Start Date
February 1 2010
End Date
December 1 2011
Last Update
December 17 2010
Active Locations (3)
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1
IRCCS "Casa Sollievo della Sofferenza"-Thrombosis and Haemostasis Center
San Giovanni Rotondo, FG, Italy, 71013
2
Thrombosis and Hemostasis Center-University of L'Aquila
L’Aquila, Italy, 67100
3
Hematology Department-University of Palermo
Palermo, Italy