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.
ID
Bron
Aandoening
To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous deep venous thrombosis or pulmonary embolism.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Symptomatic DVT during pregnancy and 6 weeks postpartum;<br>
2. Symptomatic PE during pregnancy and 6 weeks postpartum.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Publiek
Dept. of Vascular Medicine<br>
Meibergdreef 9, room F4-138
S.M. Bleker
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662458
info@highlowstudie.org
Wetenschappelijk
Dept. of Vascular Medicine<br>
Meibergdreef 9, room F4-138
S.M. Bleker
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662458
info@highlowstudie.org
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3731 |
| NTR-old | NTR3894 |
| CCMO | NL40326.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON55412 |