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Enrolling by invitation NCT06622187

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

Phase IV Interventional Bleeding Transplant, Kidney Desmopressin Kidney Biopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Desmopressin (DDAVP), Sodium Chloride.
Who it may be relevant to
Registry conditions: Bleeding, Transplant, Kidney, Desmopressin, Kidney Biopsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies: a Double-blind Randomized Study

Overview

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

  • Drug Desmopressin (DDAVP)
    Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure
  • 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

Primary outcome measures

  • Bleeding events [Time frame: Immediately post-biopsy until 48 hours post-biopsy]
Secondary outcome measures (2)
  • Major bleeding [Time frame: Immediately post-biopsy until 48 hours post-biopsy]
  • Minor bleeding [Time frame: Immediately post-biopsy until 48 hours post-biopsy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Hospital de Clinicas de Porto Alegre — Porto Alegre

Publications

  • 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 39114394
  • 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 32775817
  • 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 35962638
  • 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 21354681
  • 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. PMID 6401193

Identifiers

NCT: NCT06622187 · 2024-0270

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗