Working… Menu
Trial record 16 of 456 for:    Inherited Bleeding Disorder

Evaluation of Menses in Congenital Bleeding Disorders (MEVA-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261936
Recruitment Status : Unknown
Verified December 2010 by University of L'Aquila.
Recruitment status was:  Recruiting
First Posted : December 17, 2010
Last Update Posted : December 17, 2010
Information provided by:
University of L'Aquila

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 to define this symptom: 60 on each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported.

This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions:

  1. Definition of the entity of menstrual blood losses in women affected by CBDs
  2. Elaboration of specific treatment schedules for each type of CBD
  3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

Condition or disease
Von Willebrand Disease Congenital Coagulation Factors Deficiency Haemophilia Carriers

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 Bleeding Disorders (CBDs).

The evaluation of menstrual losses represents a scarcely studied field in this specific subset of patients (1), but it is very interesting because of the high incidence of menorrhagia,changeable according to each type of CBDs, but between 60 and 100% in women in the fertile age.

The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses),is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. QUEM has already been validated in preliminary in vitro and ex vivo studies (both in 87 healthy women and in women with CBDs), by comparing it with the gold standard, the Alkaline Haematin Method. A correlation coefficient close to 1 was obtained.

In the current study QUEM will be applied to women in the fertile age (between 18 e 45 years),with an ascertained diagnosis of CBD (FVII, FX, FII deficiencies, Glanzmann and von Willebrand disease, symptomatic Hemophilia A and B carriers), followed up for heavy periods at their reference hemophilia centre and needing a specific treatment will be enrolled in this multicentric study. Also women with apparently normal menses but a severe bleeding disorder will be enrolled. Women with ascertained menorrhagia will be treated with specific replacement therapies, already commonly adopted in clinical practice based on the type of CBD and scheduled to reduce heavy periods.

The study will evaluate 4 consecutive menstrual cycles, the first and the second period without treatment (when possible) and the following two by the administration of the specific treatment.

The bleeding anamnesis (bleeding score) will be performed by applying an international reference method, already validated in von Willebrand Disease type 1 (vWD1) [2] and adopted in an Italian multicentric study on 814 patients affected by different types of VWD [3]. The determination of this score has been considered useful also for other CBDs. This study has already been approved by the IRC of "San Salvatore Hospital"- L'Aquila-Italy. The study is already enrolling, in Italy, women. All the needed materials and equipments will be provided; patients will be carefully informed about the objectives of the study and they will follow a short course illustrating the use and the characteristics of the method proposed (QUEM).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders
Study Start Date : February 2010
Estimated Study Completion Date : December 2011

women with a diagnosis of CBD
women in the fertile age, with an ascertained diagnosis of CBD, followed up for heavy periods and needing a specific treatment.

Primary Outcome Measures :
  1. Quantitative determination of menstrual blood losses [ Time Frame: 1 year ]
    Quantitative determination of menstrual blood losses in women in the fertile age( between 18 and 45 years) affected by an inherited haemorrhagic disorder diagnosed on the basis of the current International Standard Criteria.This study is preliminary to the evaluation of the efficacy of each

Secondary Outcome Measures :
  1. kinetic definition of menses [ Time Frame: monthly ]
    Kinetic definition of menses (hours and days of flow) with and without specific treatment

  2. Influence of treatment on menstrual blood losses [ Time Frame: monthly ]
    To define the influence of substitutive therapies on menstrual losses

  3. treatment schedule evaluation [ Time Frame: monthly ]
    Elaboration of specific treatment schedules for each type of CBD, as evaluated by QUEM

Biospecimen Retention:   Samples With DNA
Vacuum sealed soiled pads and tampons, will be weighted and than opportunely discarghed

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women affected by CBDs and candidated to receive, as commonly performed in clinical practice a specific substitutive therapy or Desmopressine (rFVIII, rFVIIa, Desmopressine , FVIII concentrates rich in VWF, Activated Prothrombin Complex) will be followed for four consecutive menseses .The number of women enrolled will be between 30 and 50, regardless of parity.

Inclusion Criteria:

  1. Age between 18 and 45 years;
  2. Ascertained diagnosis of one of the following inherited bleeding disorders:

    1. Von Willebrand Disease type 1, 2, 3 severe and moderate (VWF:RCo < 30 %),as diagnosed following Italian guidelines [4]
    2. Glanzmann Thromboasthenia
    3. Congenital Coagulation Factor VII, II or X deficiency
    4. A and B Haemophilia Carriers (Factor VIII and IX <25%);
  3. Bleeding Severity score > 2
  4. Signing the consent form.

Exclusion Criteria:

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


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 identifier (NCT number): NCT01261936

Layout table for location information
IRCCS "Casa Sollievo della Sofferenza"-Thrombosis and Haemostasis Center Active, not recruiting
San Giovanni Rotondo, FG, Italy, 71013
Thrombosis and Hemostasis Center-University of L'Aquila Recruiting
L'Aquila, Italy, 67100
Contact: napolitano   
Hematology Department-University of Palermo Not yet recruiting
Palermo, Italy
Contact: siragusa   
Sponsors and Collaborators
University of L'Aquila
Layout table for investigator information
Study Director: guglielmo mariani, md ospedale "san salvatore"

Additional Information:
Layout table for additonal information
Responsible Party: Napolitano Mariasanta,MD, Ospedale Sna Salvatore-U.O.C. di Medicina Interna ed Ematologia-L'Aquila Identifier: NCT01261936     History of Changes
Other Study ID Numbers: MEVA-3
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: December 2010
Keywords provided by University of L'Aquila:
Congenital Bleeding Disorders(CBDs)
Diagnosis and treatment of menorrhagia in CBDs
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemostatic Disorders
Blood Coagulation Disorders
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Pathologic Processes