Main: Investigate the cyclic variation in clot lysis time in women with HMB in comparison to controls. Secondary:- Investigate the cyclic variation in TAFI, PAI-1, tPA, PI, thrombin generation, fibrinogen, fibrin clot permeability and confocal…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
clot lysis time in patients and controls.
Secondary outcome
Thrombin activatable fibrinolysis inhibitor, plasminogen activator inhibitor-1,
tissue plasminogen activator, plasmin inhibitor, thrombin generation,
fibrinogen, fibrin clot permeability and confocal microscopy analysis of fibrin
clots .
Progestagen and Body Mass Index.
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.
Heavy menstrual bleeding (HMB) is known to be associated with gynaecological
abnormalities and can also be associated with a wide range of haemostatic
disorders.
There is also evidence that fibrinolysis in the endometrium plays an important
role in menstruation. In women with menorrhagia increased fibrinolytic activity
was observed in the menstrual fluid which suggested that this might be a
contributing factor in the etiology of heavy menstrual bleeding. Notably, the
role of systemic fibrinolysis in women with HMB was not studied yet. Results
from our previous study showed no increased systemic fibrinolysis in women with
HMB. Inhibitors of fibrinolysis (thrombin activatable fibrinolysis inhibitor
(TAFI) and plasmin inhibitor (PI)) were even higher in patients with heavy
menstrual bleeding. An explanation why we found no increased systemic
fibrinolysis could be the moment of testing in the menstrual cycle. Probably
there is cyclic variation in menstruating women with menorrhagia. This
hypothesis needs to be tested by measuring fibrinolytic parameters during the
menstrual cycle.
Study objective
Main: Investigate the cyclic variation in clot lysis time in women with HMB in
comparison to controls.
Secondary:- Investigate the cyclic variation in TAFI, PAI-1, tPA, PI, thrombin
generation, fibrinogen, fibrin clot permeability and confocal microscopy
analysis of fibrin clots in women with HMB in comparison to controls.
- Investigate the ovulatory menstrual cycle by measuring progestagen.
Study design
Observational cross-sectional study.
Study burden and risks
Burden and risks: patients are asked to fill out a questionnaire (duration
around 15 minutes). For patients of the UMCG 18 cc of extra blood will be
taken when blood is drawn for other reasons, such as full blood count (i.e. no
extra venapunction). For the patients of the Martini Hospital this venapunction
is not performed at the same time of a routine laboratory measurement. The
controls or the healthy female volunteers are asked to fill out the same
questionnaire and we will be taking 18 cc of blood for multiple samples in a
single venapunction. The patients and controls need to come back 3 times for
blood withdrawal. This will be at week 2 (day 12-16, 18 cc of blood), week 3
(day 19-23, 23 cc of blood) and week 4 (day 26-30, 18 cc of blood). There are
no benefits for the patients and controls.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Healthy controls with regular menstrual blood loss.
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 (NSAID*s).
4. a Body Mass Index >30 kg/m2.
- 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 (NSAID*s).
4. uterine fibroids > 2 cm in diameter.
5. a Body Mass Index >30 kg/m2.
6. PBAC-score <200 points.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50151.042.14 |
| OMON | NL-OMON22702 |