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Enrolling by Invitation

NCT Number: NCT06622187

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

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.

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Key information

Conditions

Bleeding Desmopressin Hemorrhage Kidney Biopsy Pathologic Processes Pathological Conditions, Signs and Symptoms Transplant, Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desmopressin (DDAVP)

Drug

Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure

Sodium Chloride

Drug

Patients in the control group will receive sodium chloride 0.9% 100mL administered as an intravenous infusion 1h before the proposed procedure

Primary outcomes

  1. Bleeding events

    Time frame: Immediately post-biopsy until 48 hours post-biopsy

    Incidence of bleeding related to the procedure

Secondary outcomes

  1. 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

  2. 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%

Other outcomes

  1. Number of participants with hyponatremia, skin reaction, anaphylaxis

    Time frame: Immediately pre-biopsy until 24 hours post-biopsy

    Number of participants with hyponatremia, skin reaction, anaphylaxis [Safety and Tolerability]

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Acronym: BRIDGE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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