|- candidate number||14495|
|- NTR Number||NTR3894|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2013|
|- Secondary IDs||NL40326.018.12 / 2012-347; CCMO / METC AMC|
|- Public Title||Highlow study.|
|- Scientific Title||Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: A randomized controlled trial of two doses.|
|- hypothesis||Intermediate weight-adjusted dose LMWH for VTE prophylaxis in pregnant women with a previous history of VTE is more efficacious than fixed low dose LMWH without increasing bleeding risk.|
|- Healt Condition(s) or Problem(s) studied||Delivering women, Deep vein thrombosis , Pulmonary embolism, Low molecular weight heparin (LMWH)|
|- Inclusion criteria||1. Age > 18 years;|
2. Pregnancy confirmed by urinary pregnancy test;
3. Gestational age < 14 weeks since first day of last menstrual period;
4. Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).
|- Exclusion criteria||1. Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor;|
2. Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy);
3. Inability to provide informed consent;
4. Type 1 allergy to LMWH preparations;
5. Confirmed heparin-induced thrombocytopenia;
6. Renal insufficiency (creatinine clearance < 30ml/min);
7. Previous inclusion in the Highlow study (for another pregnancy).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mrt-2013|
|- planned closingdate||15-sep-2016|
|- Target number of participants||1000|
|- Interventions||Intermediate dose LMWH. Two different doses will be tested. LWMH will be administered until 6 weeks postpartum.
Low doses: Nadroparin (Fraxiparine): 2850 IE 1dd1 s.c.; dalteparin (Fragmin): 5000 IU 1dd1 s.c.; tinzaparin (Innohep): 4500 IU 1dd1 s.c.; enoxaparin (Clexane): 40 mg 1dd1 s.c.
Intermediate doses: weight adjusted according to dosing scheme in protocol.
|- Primary outcome||1. Symptomatic DVT during pregnancy and 6 weeks postpartum;|
2. Symptomatic PE during pregnancy and 6 weeks postpartum.
|- Secondary outcome||1. Symptomatic DVT during pregnancy until 3 months postpartum;|
2. Symptomatic PE during pregnancy until 3 months postpartum.
|- Timepoints||1. Inclusion (visit);|
2. 2 weeks after treatment (visit);
3. 20 weeks after treatment (phone or visit);
4. 30 weeks after treatment (phone or visit);
5. 1 week after delivery (phone or visit);
6. 6 weeks after delivery (phone);
7. 3 months after delivery (phone).
|- Trial web site||www.highlowstudy.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S.M. Bleker|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Middeldorp|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|GlaxoSmithKline, NWO, Academic Medical Center (AMC)|
|- Brief summary||This is a randomized-controlled open-label trial comparing two different doses of LMWH in pregnant patients with a history of previous VTE. Both doses are recommended doses in the ACCP guidelines.|
Patients enter the study as soon as a home test confirms pregnancy. LWMH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum.
Patients will be recruited by their treating physician, either an obstetrician or internist.
|- Main changes (audit trail)|
|- RECORD||12-mrt-2013 - 23-mrt-2013|