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临床试验/NCT05108389
NCT05108389进行中(未招募)不适用

Sonoclot to Evaluate Thrombotic Risk in Proteinuric Pregnancy

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
13
试验地点
1
主要终点
Proteinuria (log) to clot time correlation

研究概览

简要总结

There is a lack of consensus on whether women with proteinuric kidney disease benefit from prophylactic anticoagulation during pregnancy to reduce the risk of venous thromboembolism.

This pilot study will investigate the feasibility of obtaining thrombosis profile data using a viscoelastic haemostasis monitor - Sonoclot - from pregnant women with kidney disease, and exploratory analyses to elucidate correlations between output values and clinical parameters

详细描述

Pregnancy is a risk factor for women developing blood clots in veins (VTE). The risk is highest towards the end of pregnancy and in the few weeks following delivery. VTE can cause swollen painful legs due to clots in the deep veins (DVT) and/or blood clots in the lung vessels leading to chest pain, breathlessness and loss of blood pressure. VTE is the leading direct cause of death in pregnant women in the UK (affecting 1.4 per 100,000 pregnancies). Additional risk factors for VTE (including obesity, family history, previous history of blood clots and Caesarean section) are routinely valuated through standard care and treatment to thin blood with low molecular weight heparin (LWMH) injections is offered to those at highest risk. Women with kidney disease comprise a very small proportion of all pregnancies and are hence under-represented in large-scale studies to evaluate VTE risk.

Outside of pregnancy, patients with kidney conditions associated with heavy leakage of protein into urine through damaged microscopic filters (glomeruli) plus low blood protein plus swelling (the "nephrotic syndrome") have an increased risk of VTE. VTE risk is increased as a result of (a) concentration of blood within blood vessels due to fluid leak into tissues, (b) decreased flow of blood through veins due to circulating volume and decreased mobility and (c) an imbalanced loss of proteins in urine that favour or inhibit blood clotting. There is evidence to support blood thinning treatment to reduce the risk of VTE in patients with one cause of nephrotic syndrome - membranous nephropathy - and many clinicians choose to offer blood thinning treatment to patients with other causes of nephrotic syndrome if they believe the patient is at increased risk of clots.

There are no clinical data to confirm a benefit of blood thinning treatments to prevent VTE in pregnant women with nephrotic syndrome, but, faced with the lack of published studies, consensus guidelines published in 2018 recommend that women with nephrotic syndrome should be treated during pregnancy and for 6 weeks after birth.

There is a lack of consensus on whether women with less severe protein leak during pregnancy should be offered blood thinning injections. An international survey of clinicians caring for women with these conditions reports a wide range in practice from some offering treatment to all with a protein leak (urine protein:creatinine ratio) >100mg/mmol, to others only considering treatment if leak was >300mg/mmol AND evidence of low blood protein AND swelling.

VTE prophylaxis with LMWH is standard of care for medical in-patients and for out-patient treatment in pregnant women identified to be at increased VTE risk. Although LMWH treatment is not associated with any adverse pregnancy outcomes, it is uncomfortable, inconvenient and can interfere with delivery plans if spinal or epidural anesthetic is required.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed pregnancy by ultrasound scanning or urine or serum beta-HCG
  • Chronic kidney disease stage 1 to 5, defined as abnormalities of serum creatinine, urine constituents or renal tract anatomy for more than 3 months, or genetic traits associated with renal disease

排除标准

  • Known primary thrombophilia (including factor V Leiden, prothrombin mutations, protein C deficiency, protein S deficiency)
  • Treatment with low molecular weight heparin in 24 hours prior to consent
  • Suspected or confirmed active pre-eclampsia or superimposed pre-eclampsia

结局指标

主要结局

Proteinuria (log) to clot time correlation

时间窗: Through study completion, an average of 9 months

Univariate linear regression analysis of clot time vs log\[urine protein:creatinine ratio\]

次要结局

  • Proteinuria (<>100mg/mmol) to clot time correlation(Through study completion, an average of 9 months)
  • Proteinuria (<>300mg/mmol) to clot time correlation(Through study completion, an average of 9 months)
  • Proteinuria to clot time correlation(Through study completion, an average of 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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