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Highlow study.


- candidate number14495
- NTR NumberNTR3894
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2013
- Secondary IDsNL40326.018.12 / 2012-347; CCMO / METC AMC
- Public TitleHighlow study.
- Scientific TitleLow-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: A randomized controlled trial of two doses.
- ACRONYM
- hypothesisIntermediate 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) studiedDelivering women, Deep vein thrombosis , Pulmonary embolism, Low molecular weight heparin (LMWH)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2013
- planned closingdate15-sep-2016
- Target number of participants1000
- InterventionsIntermediate 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 outcome1. Symptomatic DVT during pregnancy and 6 weeks postpartum;
2. Symptomatic PE during pregnancy and 6 weeks postpartum.
- Secondary outcome1. Symptomatic DVT during pregnancy until 3 months postpartum;
2. Symptomatic PE during pregnancy until 3 months postpartum.
- Timepoints1. 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 sitewww.highlowstudy.org
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.M. Bleker
- CONTACT for SCIENTIFIC QUERIESDr. S. Middeldorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline, NWO, Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryThis 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)
- RECORD12-mrt-2013 - 23-mrt-2013


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