Clinical trial NCT06622187: Use of Desmopressin Prior to Graft Kidney Biopsy in Patients with High Risk of Bleeding
Official title: Use of Desmopressin Prior to Graft Kidney Biopsy in Patients with High Risk of Bleeding: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Bleeding
Transplant, Kidney
Desmopressin
Kidney Biopsy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant patients with GFR \&lt;60ml/min/1,73m²
* Need for graft biopsy as indicated by the kidney transplant medical team
* Platelets \&gt;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

Primary outcomes:
measure: Bleeding events
timeFrame: Immediately post-biopsy until 48 hours post-biopsy
Secondary outcomes:
measure: Major bleeding
timeFrame: Immediately post-biopsy until 48 hours post-biopsy
measure: Minor bleeding
timeFrame: Immediately post-biopsy until 48 hours post-biopsy
Other outcomes:
measure: Number of participants with hyponatremia, skin reaction, anaphylaxis
timeFrame: Immediately pre-biopsy until 24 hours post-biopsy
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Clinicas de Porto Alegre
name: Andrea Bauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.