Safety Outcomes Post kidney Biopsy – randomized Clinical Evaluation of Efficacy of Desmopressin - STOP BLEED

Medical University of Bialystok0 个研究点目标入组 424 人开始时间: 2022年3月8日最近更新: 2024年9月2日

试验速览

暂无简介。

•1.= 18 years old
•2.Ability to provide Informed Consent
•3.Qualification by nephrologist to kidney biopsy in accordance to current standards
•4.Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/µL
•5.Normal range of APTT and INR
•6.Blood pressure control defined as SBP<160 mmHg
•7.Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin
•8.No inflammation at the point of biopsy needle insertion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•1. Initial sodium concentration <130mmol/l
•2.Pregnancy and breastfeeding
•3.Anaphylactic shock after desmopressin administration (medical history)
•4.Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
•5.Decompensated Heart failure
•7.Von Willebrand disease (VWD) type II B
•8.As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
•10.Hydronephrosis of the biopsied kidney
•11.Usage of any prohibited drug before screening :
•ASA in dosage > 75mg per day
•Vitamin K antagonist (VKA)
•Direct oral anticoagulants (DOAC)
•Low-molecular-weight heparin (LMWH)
•Unfractionated heparin (UFH)
•Except situation when dosage of listed above drugs will be adjusted in accordance to protocol

发起方

Medical University of Bialystok