Systemic fibrinolysis in women with menorrhagia

Completed

• Conditions: heavy menstrual bleeding; menorrhagia; 10064477; 10013326

• Registration Number: NL-OMON42249
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>clot lysis time in patients and controls. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Thrombin activatable fibrinolysis inhibitor, plasminogen activator inhibitor-1,<br /><br>tissue plasminogen activator, plasmin inhibitor, thrombin generation,<br /><br>fibrinogen, fibrin clot permeability and confocal microscopy analysis of fibrin<br /><br>clots .<br /><br>Progestagen and Body Mass Index. </p><br>