Desmopressin: desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;
intravenous infusion NaCl: 0,9% NaCl managed as intravenous infusion
Study summary
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
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Bleeding events in 24 hours after the procedure — 24 hours after kidney biopsy 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 — 48 hours after kidney biopsy 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.
Trial sites (1)
Facility
City
Region
Status
II Department of Nephrology and Hypertension
Bialystok
Poland
Recruiting
More Medical University of Bialystok trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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