Atenativ Effect on Uterine Blood Flow and Preeclampsia

NCT02278575 | Withdrawn Phase 4 DMC

• 1 other identifier: EudraCT 2012-005770-57
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antithrombin III Deficiency

Keywords

antithrombin, Atenativ, preeclampsia, blood flow.

Outcome Measures

Primary Outcomes (1)

• Blood flow in uterin and umbilical artery

  up to day 14

Secondary Outcomes (2)

• fetal outcome

  at birth

• bleeding complications

  during pregnancy and at delivery

Other Outcomes (2)

• Biomarkers of endothelial damage

  up to day 14

• Atenativ concentrate

  treatment during 2 weeks

Study Arms (1)

Consisting of treatment with Atenativ

OTHER

During two weeks antithrombin concentrate(Atenativ) will be administered in order to maintain normal levels of antithrombin

Drug: Atenativ

Interventions

Atenativ DRUG

intravenous transfusion

Also known as: antithrombin concentrate

Consisting of treatment with Atenativ

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman in gestational week 23+0 - 29+0
• 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.
• AT level \<0.8 kIE/L

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Octapharma: collaborator

Study Sites (1)

Dept Obstetrics, Sahlgrenska University Hospital

Gothenburg, 41685, Sweden

Location

Related Publications (9)

• 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.

  PMID: 17636190 RESULT

• 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.

  PMID: 6872275 RESULT

• 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.

  PMID: 2329037 RESULT

• 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.

  PMID: 6618278 RESULT

• 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.

  PMID: 6484893 RESULT

• 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.

  PMID: 11057854 RESULT

• 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.

  PMID: 14719181 RESULT

• 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.

  PMID: 15500369 RESULT

• 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.

  PMID: 18226126 RESULT

MeSH Terms

Conditions

Antithrombin III Deficiency; Pre-Eclampsia

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Protein Disorders; Thrombophilia; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Alpha-Globulins; Serum Globulins; Blood Proteins; Proteins; Globulins; Blood Coagulation Factor Inhibitors; Biological Factors

Study Officials

• Margareta Hellgren, MD,PhD,prof

  department Obstetrics, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 30, 2014
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)