Main: To confirm the findings of our previous, explorative study that the overall FXI plasma levels in patients with menorrhagia are lower than in controls. Secondary: To establish the prevalence of FXI mutations/polymorfisms in patients with…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Chromosomal abnormalities, gene alterations and gene variants
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma FXI levels.
Secondary outcome
FXI gene mutations/polymorfisms.
Prevalence of bleeding disorders in patients with menorrhagia.
Background summary
Menorrhagia is a common problem among women in the reproductive age. At least 5
-10% of women in reproductive age will seek medical attention for menorrhagia.
Menorrhagia can be caused by a wide range of disorders. In the past decade
underlying bleeding disorders, such as Von Willebrand disease, have been
recognized as an important etiologic and/or contributory factor. Nevertheless,
haemostatic evaluation is uncommon in routine gynaecological practice.
Preliminary results from our previous study of 102 patients with menorrhagia
and 28 volunteers showed, unexpectedly, that patients had significantly lower
levels of factor XI (FXI) compared to controls (100 vs 125 IU/dL; p<0.001) Of
all the patients, four had a FXI level deficiency (<70%). This finding needs to
be replicated and explained by analysis of the factor XI gene.
Study objective
Main: To confirm the findings of our previous, explorative study that the
overall FXI plasma levels in patients with menorrhagia are lower than in
controls.
Secondary: To establish the prevalence of FXI mutations/polymorfisms in
patients with menorrhagia in comparison to controls.
To establish the prevalence of other bleeding disorders in women with
menorrhagia.
Study design
Observational study.
Study burden and risks
Burden and risks: patients are asked to fill out a questionnaire (duration
around 15 minutes). 30 cc extra blood will be taken when blood is drawn for
other reasons, such as full blood count (i.e. no extra venapunction). The
healthy female volunteers are asked to fill out the same questionnaire and we
will be taking 30 cc of blood for multiple samples in a single venapunction.
There are no benefits for the healthy volunteers. The patients get a
coagulation work-up. If we find a bleeding disorder, the patient and the
treating physician will be informed about the bleeding disorder. Besides the
risk associated with venapunction, there are no risks for participants of the
study.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Healthy controls with regular normal menstrual bleeding
Age *18 years
Written informed consent
- Patients with regular heavy menstrual bleeding (<=menorrhagia)
Age *18 years
Written informed consent
Exclusion criteria
- Healthy controls with:
1. postmenopausal, postcoital or intermenstrual bleeding.
2. an intra-uterine device or hormonal treatment.
3. anticoagulant, antithrombotic therapy or use of non-steroidal anti-inflammatory drugs (NSAIDs).
- Patients with:
1. postmenopausal, postcoital or intermenstrual bleeding.
2. an intra-uterine device or hormonal treatment.
3. anticoagulant, antithrombotic therapy or use of non-steroidal anti-inflammatory drugs (NSAIDs).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42716.042.12 |