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โ† Trials
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Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin

RecruitingPhase 3Ages 18 Years - 99 YearsAllMedical University of Bialystok
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In plain words

What the trial is, and whether it could suit you

It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. โ‰ฅ 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/ฮผL 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 Exclusion Criteria: 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 6. Von Willebrand disease (VWD) type II B 7. As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP) 8. Hydronephrosis of the biopsied kidney 9. 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
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What it tests

  • Desmopressin
  • intravenous infusion NaCl
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Where

1 site
II Department of Nephrology and Hypertension
Bialystok, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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