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Transfusion strategies in women during Major Obstetric Haemorrhage


- candidate number15148
- NTR NumberNTR4079
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jul-2013
- Secondary IDsP12.273 MEC Leiden University Medical Center
- Public TitleTransfusion strategies in women during Major Obstetric Haemorrhage
- Scientific TitleTransfusion strategies in women during Major Obstetric Haemorrhage
- ACRONYMTeMpOH-1
- hypothesis
- Healt Condition(s) or Problem(s) studiedBlood loss, Pregnancy, Labour
- Inclusion criteriaTransfusion of FFP and/or platelets alongside RBC transfusion AND Obstetric haemorrhage in pregnancy (including early pregnancy), during the first 24 hours following delivery or in puerperium (limited to 6 weeks after delivery).
- Exclusion criteriaTiming of transfusion of blood components not recorded or not obtainable.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 22-apr-2013
- planned closingdate1-apr-2014
- Target number of participants1600
- InterventionsN/A
- Primary outcomeMaternal mortality and severe maternal morbidity. Severe maternal morbidity will be defined as a postpartum hysterectomy, postpartum arterial embolisation and/or intensive care unit admission.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web sitewww.studies-obsgyn.nl/tempoh-1
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESD.D.C.A. Henriquez
- CONTACT for SCIENTIFIC QUERIESD.D.C.A. Henriquez
- Sponsor/Initiator Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening), Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Blood Supply
- PublicationsN/A
- Brief summaryMajor obstetric haemorrhage is the most important cause of severe maternal morbidity. Observational studies on massive haemorrhage associated with trauma and surgery have shown an apparent survival advantage with the administration of high cumulative ratios plasma and platelets to red blood cells. However, these results may have been confounded due to reverse causation and do not take time-varying treatment and time-dependent confounding into account. Furthermore, some authors recently proposed that not the ratios between the transfused blood components determine the outcome, but rather the timing of transfusion of plasma and platelets. Administration of plasma and platelets early on in treatment would prevent and timely correct coagulopathy during ongoing blood loss, and would thus lead to more favourable outcomes. The aim of this study is to determine the effect of early administration of plasma and platelets alongside RBCs on the clinical course of women with obstetric haemorrhage compared to administration at a later stage in treatment. Women that received FFP and/or platelets alongside RBCs due to obstetric haemorrhage, in 2011 and 2012 in the Netherlands, will be identified by cross-referencing data from departments of blood transfusion services with data from local birth registers. Data on characteristics of and treatment of selected women will be collected by performing a chart review of patients. The effect of timing of transfusion of FFP and/or platelets in conjunction with RBC transfusion on maternal mortality and severe maternal morbidity will be determined by using an inverse probability weighted Cox proportional hazard model.
- Main changes (audit trail)
- RECORD17-jul-2013 - 2-aug-2013


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