Tiny study on clotting disorder and artery health ends early
NCT ID NCT01160159
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to see if women with thrombophilia (a condition that makes blood clot more easily) have differences in artery function compared to healthy women. Researchers planned to measure blood vessel dilation and other artery health markers. However, the study was terminated early after enrolling only 6 participants, so no meaningful conclusions could be drawn.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
6 people
The number who actually took part.
- Started
-
Mar 2010
- Finished
-
Apr 2010
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.
- Ages
-
18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * healthy volunteers * 18-45 years old women of child bearing age * Without any hormonal contraception nor any hormone treatment since at least 3 months * Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\> 5 cigaret ) * Patient who have signed an inform consent * With no thrombophilia : normal sample for factor V and II mutations * Willing to participate to the study * Adherent to health insurance * Previous Clinical examination * women with thrombophilia * 18-45 years old women of child bearing age * Without any hormonal contraception nor any hormone treatment since at least 3 months * Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking\> 5 cigaret ) * Patient who have signed an inform consent * With thrombophilia : normal sample for factor V and II mutations * Willing to participate to the study * Adherent to health insurance * Previous Clinical examination Exclusion Criteria: * Women under hormonal contraception or who have stopped it less than 3 months ago * Women under anticoagulant * Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI\>30), including smoking\> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE * History of coronaropathy or of stroke * Pregnant women or willing to conceive * Severe liver disease * Women of less than 18y or older than 45y * Severe liver diseases * Patient not willing to sign up the inform consent * Patient refusal to participate * Endometrial cancer * Unexplored bleeding * Women not willing to participate or included in another trial * Woman with another thrombophilic disorder (ATIII, protein C, S, history of VTE without any biological thrombophilic disorder. * Women with at least one of the following treatment and who cannot stop it 48h before the arterial investigations. * Gynergen caffeine * NOCERTONE® oxetorone * SIBÉLIUM®flunarizine * VIDORA®indoramine * SANMIGRAN® 0,50 mg pizotifen * woman under propranolol AVLOCARDYL® 40 mg \*AVLOCARDYL® LP 160 mg
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase
Paris, 75004, France
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