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Validation of the thrombin generation assay in pregnancy


- candidate number19436
- NTR NumberNTR4782
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2014
- Secondary IDsMETC 14-4-063 
- Public TitleValidation of the thrombin generation assay in pregnancy
- Scientific TitleValidation of the thrombin generation assay in pregnancy
- ACRONYM
- hypothesisAim of the study is to receive reference ranges for a plasma and a whole blood thrombingeneration assay.
- Healt Condition(s) or Problem(s) studiedPregnancy
- Inclusion criteriaAll healthy, adult women who are in the final trimester of their pregnancy.
- Exclusion criteriaAcquired and inherited coagulation abnormalities.
HELLP-syndrome and pre-eclampsia.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-sep-2014
- planned closingdate20-jan-2015
- Target number of participants120
- InterventionsNo intervention planned.
This study is observational.
- Primary outcomePrimary outcome is a reference range for a plasma thrombin generation assay and a newly developed whole blood thrombin generation assay.
- Secondary outcomeCorrelation with peri-partal bleeding.
- TimepointsIn the final trimester before delivery patients comimng to the policlinics and/or for hospital admission will be asked to participate. After informed consent 18ml citrated blood will be drawn during a regular blood drawing.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M.D. LancÚ
- CONTACT for SCIENTIFIC QUERIESDr. M.D. LancÚ
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN. M. de Lange*, L. E. van Rheenen-Flach, M. D. Lance┤ , L. Mooyman4, M.Woiski, E. C. van Pampus,M. Porath, A. C. Bolte2, L. Smits, Y. M. Henskens and H. C. Scheepers. BJA-2014: Peri-partum reference ranges for ROTEM thromboelastometry
- Brief summaryBlood of 120 pregnant women will be analysed for plasma thrombin generation and whole blood thrombin generation to create a reference range for this population.
- Main changes (audit trail)
- RECORD11-sep-2014 - 8-okt-2014


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