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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of L'Aquila.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01261936
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Von Willebrand Disease
Congenital Coagulation Factors Deficiency
Haemophilia Carriers

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • Quantitative determination of menstrual blood losses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • kinetic definition of menses [ Time Frame: monthly ] [ Designated as safety issue: No ]
    Kinetic definition of menses (hours and days of flow) with and without specific treatment

  • Influence of treatment on menstrual blood losses [ Time Frame: monthly ] [ Designated as safety issue: No ]
    To define the influence of substitutive therapies on menstrual losses

  • treatment schedule evaluation [ Time Frame: monthly ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261936

Locations
Italy
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       marysanta@libero.it   
Hematology Department-University of Palermo Not yet recruiting
Palermo, Italy
Contact: siragusa       sergio.siragusa@unipa.it   
Sponsors and Collaborators
University of L'Aquila
Investigators
Study Director: guglielmo mariani, md ospedale "san salvatore"
  More Information

Additional Information:
No publications provided

Responsible Party: Napolitano Mariasanta,MD, Ospedale Sna Salvatore-U.O.C. di Medicina Interna ed Ematologia-L'Aquila
ClinicalTrials.gov Identifier: NCT01261936     History of Changes
Other Study ID Numbers: MEVA-3
Study First Received: December 16, 2010
Last Updated: December 16, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of L'Aquila:
Menorrhagia
Congenital Bleeding Disorders(CBDs)
Diagnosis and treatment of menorrhagia in CBDs

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemorrhagic Disorders
Hemostatic Disorders
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014