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临床试验/NCT02278575
NCT02278575撤回4 期

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

Vastra Gotaland Region1 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
Blood flow in uterin and umbilical artery

研究概览

简要总结

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.

详细描述

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. In addition to conventional therapy, i.v. administration of Atenativ will be given in a dosage aimed to raise the plasma level of AT initially to 120% (1.2 kIU/L) The goal is to achieve and maintain plasma activity of about 100% during two weeks. The dose of Atenativ is based on the actual plasma level of AT measured 2 hours before the dose. During the first two days of treatment plasma samples will be drawn for the measurement of AT activity twice a day, once before and 12 hours after infusion in order to monitor the dosage. Thereafter and until study discontinuation AT will be measured once a day. The treatment will continue for two weeks if plasma AT III is below 100% (1.0 kIU/L).Uterine blood flow is measured before, during and after the AT infusion. Demographic data, medical history and other background data (age, weight, height, gestational week, smoker or not, gravidity, parity, previous hypertension, previous medication etc) will be recorded in order to ensure that the inclusion criteria are met and to verify patient identity and inclusion status. The week of gestation when the patient is included in the study as well as the week of gestation at delivery is recorded.

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • History of congenital AT deficiency
  • Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgments
  • Concomitant administration of anticoagulants and platelet inhibitors within 2 weeks
  • Chronic renal disease
  • Diabetes melittus or gestational diabetes
  • Intrauterine fetal death
  • Participation in another clinical study
  • Multiple pregnancies

研究组 & 干预措施

Consisting of treatment with Atenativ

Other

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

干预措施: Atenativ (Drug)

结局指标

主要结局

Blood flow in uterin and umbilical artery

时间窗: up to day 14

次要结局

  • fetal outcome(at birth)
  • bleeding complications(during pregnancy and at delivery)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Margareta Hellgren

professor, MD, PhD

Vastra Gotaland Region

研究点 (1)

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