Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin

Launched by MEDICAL UNIVERSITY OF BIALYSTOK · Jul 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called desmopressin in preventing bleeding after a kidney biopsy. The trial is taking place in Poland and involves multiple hospitals. It's specifically looking at patients who have rare types of kidney diseases known as glomerulonephritis. Participants will be randomly assigned to receive either desmopressin or a placebo (a treatment that looks the same but has no active ingredients) to see if it helps reduce the risk of bleeding during and after the procedure.

To be eligible for this trial, participants need to be at least 18 years old and must have a doctor’s approval for the kidney biopsy. They should have stable blood pressure and normal blood tests, which means their hemoglobin and blood platelet levels should be within certain ranges. Participants cannot be pregnant or breastfeeding, and they should not have certain medical conditions that could complicate the biopsy. If you join this trial, you can expect to receive careful monitoring during the study to ensure your safety and to collect valuable information on the treatment’s effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• 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