Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-01-31
2017-05-31
Brief Summary
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Detailed Description
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The type of delivery (vaginal or caesarean section as well as planned or acute) will also be recorded.. General haemostatic parameters are to be analyzed before start of treatment and then every day during treatment and thereafter at least twice a week. Special haemostatic parameters are Placental growth factor, S-Flt-1, VEGF and Syndecan-1. They will be sampled before start of treatment and during treatment once a week. The samples will be collected and frozen and not analyzed before the termination of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Consisting of treatment with Atenativ
During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
Atenativ
intravenous transfusion
Interventions
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Atenativ
intravenous transfusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Severe preeclampsia as defined by international criteria (1,2)
* Blood pressure \>160/110 mmHg (measured twice 30 minutes apart). proteinuria (\>5 .0 g/L per 24 hours or \>3 + labstick in at least two random samples six hours apart) after 20th gestational week.
* Blood pressure \>140/90 mmHg and proteinuria \>5.0 g/24 h.
* preeclampsia ( blood pressure \> 140/90 and proteinuria \>0.3 g/24 h) with IUGR or subjective symptoms as epigastic pain (HELLP), headache, dizziness or visual disturbancies, oligouri \< 600 ml/24 h, coagulation disturbancies.
3. AT level \<0.8 kIE/L
\-
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Octapharma
INDUSTRY
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Margareta Hellgren
professor, MD, PhD
Principal Investigators
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Margareta Hellgren, MD,PhD,prof
Role: PRINCIPAL_INVESTIGATOR
department Obstetrics, Sahlgrenska University Hospital
Locations
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Dept Obstetrics, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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References
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Heilmann L, Rath W, Pollow K. Hemostatic abnormalities in patients with severe preeclampsia. Clin Appl Thromb Hemost. 2007 Jul;13(3):285-91. doi: 10.1177/1076029607299986.
Weenink GH, Treffers PE, Vijn P, Smorenberg-Schoorl ME, ten Cate JW. Plasma antithrombin III levels in pre-eclampsia. Clin Exp Hypertens B. 1983;2(1):145-62. doi: 10.3109/10641958309023467.
Aghai E, Brunstein J, Quitt M, Abramovici H, Froom P. Antithrombin III levels in preeclampsia. Isr J Med Sci. 1990 Mar;26(3):142-3.
Hellgren M, Hagnevik K, Robbe H, Bjork O, Blomback M, Eklund J. Severe acquired antithrombin III deficiency in relation to hepatic and renal insufficiency and intrauterine fetal death in late pregnancy. Gynecol Obstet Invest. 1983;16(2):107-18. doi: 10.1159/000299230.
Hellgren M, Javelin L, Hagnevik K, Blomback M. Antithrombin III concentrate as adjuvant in DIC treatment. A pilot study in 9 severely ill patients. Thromb Res. 1984 Aug 15;35(4):459-66. doi: 10.1016/0049-3848(84)90237-8. No abstract available.
Maki M, Kobayashi T, Terao T, Ikenoue T, Satoh K, Nakabayashi M, Sagara Y, Kajiwara Y, Urata M. Antithrombin therapy for severe preeclampsia: results of a double-blind, randomized, placebo-controlled trial. BI51.017 Study Group. Thromb Haemost. 2000 Oct;84(4):583-90.
Kobayashi T, Terao T, Ikenoue T, Sameshima H, Nakabayashi M, Kajiwara Y, Maki M; BI 51 017 Study Group. Treatment of severe preeclampsia with antithrombin concentrate: results of a prospective feasibility study. Semin Thromb Hemost. 2003 Dec;29(6):645-52. doi: 10.1055/s-2004-815632.
Paternoster DM, Fantinato S, Manganelli F, Nicolini U, Milani M, Girolami A. Recent progress in the therapeutic management of pre-eclampsia. Expert Opin Pharmacother. 2004 Nov;5(11):2233-9. doi: 10.1517/14656566.5.11.2233.
Sameshima H, Kodama Y, Ikenoue T, Kajiwara Y. Antithrombin improves fetal condition in women with severe pre-eclampsia before 32 weeks of gestation; a randomized, double-blind, placebo-controlled trial. J Obstet Gynaecol Res. 2008 Feb;34(1):34-9. doi: 10.1111/j.1447-0756.2007.00677.x.
Other Identifiers
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EudraCT 2012-005770-57
Identifier Type: -
Identifier Source: org_study_id