CTRI/2021/12/038373招募中1 期
A Phase I clinical study of locally administered AntiPlatelet, AntiCoagulant (APAC) at the time ofvascular surgery to create a radiocephalic arterio-venous fistula (RCAVF) in patients withchronic kidney disease (CKD) to facilitate hemodialysis access.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Dialysis naïve patients with CKD stages 4 and 5 (defined as an eGFR less than 30 mL/min/1.73m2), =18 and <65 years of age of either gender, requiring
- •hemodialysis access surgery.
- •2.Patient eligible to undergo AVF surgery as determined by the nephrologist and surgeon.
- •3.Patients with appropriate vessel diameters: a radial artery and a cephalic vein diameter = 2 mm (inner-to-inner diameter), measured via duplex ultrasound.
- •4.Venous patency in the draining vein with no stenosis or thrombosis, with
- •visible, palpable, and compressible (thrombus free) vein.
- •5.Life expectancy of at least 12 months and not likely to require kidney transplantation within 3 months of administration of study medication.
- •6.Patients able to provide written informed consent and willing to follow all study requirements.
排除标准
- •1.Patients already receiving hemodialysis or who have previously undergone dialysis, successful or otherwise.
- •2.Existing AVF at any anatomical site.
- •3.Patients in whom the intended site for surgical intervention is the only potential site for an AVF.
- •4.Patients taking a contraindicated medication which will interfere with the study outcome.
- •5.Patients receiving warfarin, unfractionated heparin, LMWH or any other systemic anticoagulant, such as direct oral anticoagulants at Screening
- •6.Patients who are taking or who have taken antiplatelet agents during 30 days prior to Screening, excluding aspirin.
- •7.Patients with a history of known sensitivity to heparin or aspirin.
- •8.Patients with APTT i.e., =1.5-fold prolongation, PT >1.5 of ULN, LFT >2.5 of ULN, Hb <7 g/dL
- •9.Patients with a history of myocardial infarction, stroke, peripheral arterial occlusive disease, angioplasty, previous venous thromboembolism, transient ischemic attack (TIA).
- •10.Patients with known medical history of nephrotic syndrome, arterial aneurysm, heparin-induced thrombocytopenia, inherited or acquired thrombophilic condition or symptoms of fever or active infection or any other medical condition or underlying cause for their CKD.
- •11.Patients demonstrating an absence of radial and/or ulnar arterial blood flow or non-patent palmer arch, as determined via a modified Allen test at Screening.
- •12.Patients with any systemic condition (as noted in their medical history at Screening) known to be associated with impaired hemostasis e.g., hemophilia, Von Willebrand’s disease or other bleeding disorders.
- •13.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.
- •14.Female patients who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception
- •15.Patients who for any reason, in the investigator’s opinion, are unsuitable for enrolment into the study.
研究者
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