Evaluation of Menses in Congenital Bleeding Disorders

Von Willebrand Disease Clinical Trial

— MEVA-3  

Official title:

Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01261936
• Other study ID #: MEVA-3
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2010
• Last updated: December 16, 2010
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2010
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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?).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Coagulation Factors Deficiency
• Haemophilia Carriers
• Hemorrhagic Disorders
• Hemostatic Disorders
• Von Willebrand Disease
• Von Willebrand Diseases

Locations

Country	Name	City	State
Italy	Thrombosis and Hemostasis Center-University of L'Aquila	L'Aquila
Italy	Hematology Department-University of Palermo	Palermo
Italy	IRCCS "Casa Sollievo della Sofferenza"-Thrombosis and Haemostasis Center	San Giovanni Rotondo	FG

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative determination of menstrual blood losses	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	1 year	No
Secondary	kinetic definition of menses	Kinetic definition of menses (hours and days of flow) with and without specific treatment	monthly	No
Secondary	Influence of treatment on menstrual blood losses	To define the influence of substitutive therapies on menstrual losses	monthly	No
Secondary	treatment schedule evaluation	Elaboration of specific treatment schedules for each type of CBD, as evaluated by QUEM	monthly	No

External Links

•   Diagnosis and treatment of menorrhagia