DRUG
Desmopressin (DDAVP)
Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure
Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies
Status
Enrolling by invitation
Phase
Phase 4
Enrollment
96
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
The goal of this study is to evaluate the efficacy and safety of desmopressin to prevent bleeding after percutaneous renal graft biopsy in patients at high risk of bleeding. Researchers will compare desmopressin (DDAVP) to placebo to see if the drug reduces the risk of bleeding events related to kidney biopsy. Participants will receive intravenous desmopressin medication (100ml) or placebo (100mL of saline solution) before the kidney biopsy.
Interventions
Treatment arms and agents.
DRUG
Sodium Chloride
Patients in the control group will receive sodium chloride 0.9% 100mL administered as an intravenous infusion 1h before the proposed procedure
Timeline
From registration to results.
First posted
Oct 2, 2024
Study start
Aug 14, 2024
Primary completion
Jun 2026
Study completion
Jun 14, 2026
Results posted
Not reported
Registry updated
Sep 11, 2025
Outcomes
What the study measures.
Primary outcomes
Bleeding events
Time frame · Immediately post-biopsy until 48 hours post-biopsy
Incidence of bleeding related to the procedure
Secondary outcomes
Major bleeding
Time frame · Immediately post-biopsy until 48 hours post-biopsy
Incidence of major bleeding, defined as need for transfusion of blood components, need for embolization, nephrectomy or procedure-related death
Minor bleeding
Time frame · Immediately post-biopsy until 48 hours post-biopsy
Incidence of minor bleeding, defined as presence of macroscopic hematuria, hematoma on ultrasound 24 hours post-procedure or drop in hemoglobin greater than 20%
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Kidney transplant patients with GFR \<60ml/min/1,73m² * Need for graft biopsy as indicated by the kidney transplant medical team * Platelets \>80.000 cells/mm³ * Blood pressure levels controlled before the procedure * Normal coagulogram levels Exclusion Criteria: * Pregnant women * Prior history of allergic reaction to DDAVP * Use of prohibitive medications in screening: warfarin, direct oral anticoagulants, unfractionated and low molecular weight heparin in full anticoagulation doses * History of previous blood dyscrasias
Study locations
1 registered sites.
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Publications
Results and literature.
PMID 39114394 ↗Sethi J, Bansal S, Lal A, Kohli HS, Rathi M. Role of Desmopressin Acetate before Percutaneous Ultrasound-Guided Kidney Biopsy in Patients with Kidney Dysfunction. Indian J Nephrol. 2024 May-Jun;34(3):228-232. doi: 10.4103/ijn.ijn_34_23. Epub 2023 Sep 29.PMID 32775817 ↗Leclerc S, Nadeau-Fredette AC, Elftouh N, Lafrance JP, Pichette V, Laurin LP. Use of Desmopressin Prior to Kidney Biopsy in Patients With High Bleeding Risk. Kidney Int Rep. 2020 May 20;5(8):1180-1187. doi: 10.1016/j.ekir.2020.05.006. eCollection 2020 Aug.PMID 35962638 ↗Sattari SA, Shahoori A, Shahbazian H, Sabetnia L, Aref A, Sattari AR, Ghorbani A. Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial. Iran J Kidney Dis. 2022 Jul;16(4):238-245.PMID 21354681 ↗Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26.PMID 6401193 ↗Mannucci PM, Remuzzi G, Pusineri F, Lombardi R, Valsecchi C, Mecca G, Zimmerman TS. Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia. N Engl J Med. 1983 Jan 6;308(1):8-12. doi: 10.1056/NEJM198301063080102.
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