About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old
Ability to provide Informed Consent
Qualification by nephrologist to kidney biopsy in accordance to current standards
Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/μL
Disqualifiers
Initial sodium concentration <130mmol/l
Pregnancy and breastfeeding
Anaphylactic shock after desmopressin administration (medical history)
Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
Trial design
Parallel
Treatments tested in this trial
Desmopressin
Drugdesmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;
intravenous infusion NaCl
Drug0,9% NaCl managed as intravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
Bleeding events in 24 hours after the procedure
1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration \>20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
Bleeding events in 48 hours after the procedure
1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration \>20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
Secondary outcomes
Length of hospitalization
Hospitalization time from kidney biopsy till discharge
Sponsors and contacts
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