Von Willebrand DiseaseMEVA-3NCT01261936
Evaluation of Menses in Congenital Bleeding Disorders
An observational study of Von Willebrand Disease and Congenital Coagulation Factors Deficiency, run by University of L'Aquila at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Von Willebrand Disease, Congenital Coagulation Factors Deficiency, Haemophilia Carriers
- How many people
- 30 participants
- Where
- 3 sitesItaly
- Study dates
- Feb 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 2 recruiting
- Recruiting
Thrombosis and Hemostasis Center-University of L'Aquila
L’Aquila, 67100
napolitano, marysanta@libero.it
- Not yet recruiting
Hematology Department-University of Palermo
Palermo
siragusa, sergio.siragusa@unipa.it
- Active, not recruiting
IRCCS "Casa Sollievo della Sofferenza"-Thrombosis and Haemostasis Center
San Giovanni Rotondo, FG, 71013
About this study
Official title: Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders
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:
- Definition of the entity of menstrual blood losses in women affected by CBDs
- Elaboration of specific treatment schedules for each type of CBD
- Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).
Read the 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).
- Keywords
- Menorrhagia, Congenital Bleeding Disorders(CBDs), Diagnosis and treatment of menorrhagia in CBDs
- Medical subject headings
- von Willebrand Diseases, Menorrhagia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
kinetic definition of menses
Kinetic definition of menses (hours and days of flow) with and without specific treatment
Measured: monthly
Influence of treatment on menstrual blood losses
To define the influence of substitutive therapies on menstrual losses
Measured: monthly
treatment schedule evaluation
Elaboration of specific treatment schedules for each type of CBD, as evaluated by QUEM
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startFeb 2010
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Investigators
- guglielmo mariani, md, Study director, ospedale "san salvatore"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261936
- Sponsor's protocol ID
- MEVA-3
- Acronym
- MEVA-3
- Status last verified
- Dec 2010
- First submitted
- 16 Dec 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Determination of Menstrual Blood Losses in Women Affected by Congenital Bleeding Disorders
- ClinicalTrials.gov ID
- NCT01261936
- Acronym / sponsor ID
- MEVA-3 / MEVA-3
- Keywords
- Menorrhagia, Congenital Bleeding Disorders(CBDs), Diagnosis and treatment of menorrhagia in CBDs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Feb 2010
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Definition of the entity of menstrual blood losses in women affected by CBDs
- Elaboration of specific treatment schedules for each type of CBD
- Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- Age between 18 and 45 years;
- Ascertained diagnosis of one of the following inherited bleeding disorders:
- Bleeding Severity score > 2
- Signing the consent form.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
kinetic definition of menses
Time frame: monthly
Influence of treatment on menstrual blood losses
Time frame: monthly
treatment schedule evaluation
Time frame: monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Diagnosis and treatment of menorrhagiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guglielmo mariani, md study director
ospedale "san salvatore"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Disease and Congenital Coagulation Factors Deficiency, run by University of L'Aquila at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative determination of menstrual blood losses (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.