Use of Desmopressin Prior to Graft Kidney Biopsy in Patients with High Risk of Bleeding

Phase 4

• Conditions: Bleeding; Transplant, Kidney; Desmopressin; Kidney Biopsy
• Interventions: Drug: Sodium Chloride; Drug: Desmopressin (DDAVP)

• Registration Number: NCT06622187
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-14
• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-06
• Study Completion: 2026-06-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride	Sodium Chloride	-
Desmopressin (DDAVP)	Desmopressin (DDAVP)	-

Primary Outcome Measures

Name	Time	Method
Bleeding events	Immediately post-biopsy until 48 hours post-biopsy	Incidence of bleeding related to the procedure

Secondary Outcome Measures

Name	Time	Method
Major bleeding	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	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%

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil