impossible to recruit participants due to organization changes
Clinical Effect of Atenativ Treatment on Uterine Blood Flow and the Amount of Atenativ Needed to Maintain a Normal Antithrombin Lvels During Two Weeks in Early and Severe Preeclampsia
Sponsor study identifier
interventional
0
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)The study will be an open controlled pilot study of 6 patients with early-onset severe preeclampsia. Patients will receive Atenativ in addition to conventional therapy The patients will be followed up within the study until three days after delivery. Laboratory analyses and uterine and umbiliacal blood flow will be determined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2014
Actual (reported)October 30, 2014
Actual (reported)January 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 2017
Actual (reported)May 2017
Actual (reported)Blood flow in uterin and umbilical artery
up to day 14
fetal outcome
at birth
bleeding complications
during pregnancy and at delivery
Biomarkers of endothelial damage
up to day 14
Atenativ concentrate
treatment during 2 weeks
During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin
intravenous transfusion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dept Obstetrics, Sahlgrenska University Hospital
Gothenburg, 41685, Sweden
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.
Margareta Hellgren, MD,PhD,prof
department Obstetrics, Sahlgrenska University Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2014
First Posted
October 30, 2014
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO
Contact the study team to confirm eligibility.
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.
Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)Last Updated
September 26, 2017
Record last verified: 2017-09
extern monitoring by Gothia Forum
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Source: ClinicalTrials.gov.
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