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ROTEM pilot study: A new method for measuring coagulation problems in women during labor.


- candidate number8458
- NTR NumberNTR2515
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2010
- Secondary IDsABR 32758 CCMO
- Public TitleROTEM pilot study: A new method for measuring coagulation problems in women during labor.
- Scientific TitleThe use of thromboelastometry (ROTEM®) during labor: The development of norm- and cut off values in the prediction and management of post partum hemorrhage. A pilot study.
- ACRONYMROTEM
- hypothesisIn cardiac and liver surgery, the use of tromboelastometry (ROTEM) is a cost effective strategy leading to more selective substitution management and less blood transfusions. The method has not yet been validated for pregnant women nor are there normal values for ROTEM in pregnancy.
- Healt Condition(s) or Problem(s) studiedFluxus postpartum
- Inclusion criteria1. Pregnant, > 24+0 weeks;
2. Age ≥ 18 years;
3. Informed consent;
4. Mentally competent.
- Exclusion criteria1. Labor < 24+0 weeks;
2. Prophylactic or therapeutic anticoagulant therapy (carbasalate calcium within the last 10 days or low molecular weight heparins within last 48 hours).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2010
- planned closingdate1-mrt-2011
- Target number of participants200
- InterventionsN/A
- Primary outcome1. To obtain normal 'clotting' values through ROTEM® ante partum and in the post partum period;
2. To validate these clotting values for pregnant women using conventional clotting tests as golden standard.
- Secondary outcomeTo evaluate whether the results of conventional clotting test or ROTEM can predict mild or severe HPP.
- TimepointsGain permission from medical and ethical commision Maastricht, start trial 01-11-2010 in Maastricht and in the other centres before 01-12-2010.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Natascha Lange, de
- CONTACT for SCIENTIFIC QUERIES Natascha Lange, de
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
CSL Behring
- PublicationsN/A
- Brief summaryPost partum hemorrhage (PPH) is the main cause of maternal death worldwide and the main cause of severe maternal morbidity in the Netherlands. The course of PPH is unpredictable. Timely recognition and prompt intervention are crucial for successful management. Crucial prognostic factors for the severity of PPH are a delay in obstetric management and development of secondary coagulopathy. In the usual care however, results of laboratory tests may take more than 60 minutes and are non specific. Therefore only in severe cases clotting tests are done and the regular management consists of transfusion of red blood cells and fresh frozen plasma. Evaluation of the efficacy of current treatment strategies is however lacking, also because of inadequate monitoring possibilities. In cardiac and liver surgery, the use of tromboelastometry (ROTEM) is a cost effective strategy leading to more selective substitution management and less blood transfusions.
- Main changes (audit trail)
- RECORD18-sep-2010 - 10-apr-2011


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