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Trial · Interventional

Enrolling by invitationPhase 4Registry data

Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies

Short name BRIDGE

NCTNCT06622187 (opens ClinicalTrials.gov in a new tab)Other id2024-0270
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Phase 4
Enrollment
96 participants (estimated)
Sponsor
Hospital de Clinicas de Porto Alegre · Other
Design
Randomized · Quadruple masking
Countries
1 country

Brazil

Start
14 Aug 2024
Primary completion
Jun 2026 (estimated)
Completion
14 Jun 2026 (estimated)
First posted
2 Oct 2024
Last update posted
11 Sept 2025
Conditions
Bleeding · Transplant, Kidney · Desmopressin · Kidney Biopsy

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 4

    BRIDGE

    NCT06622187

    14 Aug 2024 to est. 14 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Desmopressin (DDAVP)Drug
  • Sodium ChlorideDrug

Arms2

  • Placebo comparator

    Sodium Chloride

  • Experimental

    Desmopressin (DDAVP)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bleeding events

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

    Registry description

    Incidence of bleeding related to the procedure

Secondary outcomes(2)

  1. Major bleeding

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

    Registry description

    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

    Registry description

    Incidence of minor bleeding, defined as presence of macroscopic hematuria, hematoma on ultrasound 24 hours post-procedure or drop in hemoglobin greater than 20%

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

4 results

Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial.

Manno et al. 2011American journal of kidney diseases : the official journal of the National Kidney Foundationcited by 76

PMID 21354681DOI 10.1053/j.ajkd.2010.12.019PUB-21354681

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

4 studies on this page

PubMed tag: none · 2024

Role of Desmopressin Acetate before Percutaneous Ultrasound-Guided Kidney Biopsy in Patients with Kidney Dysfunction.

Sethi et al. 2024Indian journal of nephrologycited by 13

PMID 39114394PMC11302129DOI 10.4103/ijn.ijn_34_23PUB-39114394

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2022

Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial.

Sattari et al. 2022Iranian journal of kidney diseasescited by 15

PMID 35962638PUB-35962638

Full text at the publisher
Publisher page

PubMed tag: none · 2020

Use of Desmopressin Prior to Kidney Biopsy in Patients With High Bleeding Risk.

Leclerc et al. 2020Kidney international reportscited by 23

PMID 32775817PMC7403497DOI 10.1016/j.ekir.2020.05.006PUB-32775817

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 1983

Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia.

Mannucci et al. 1983The New England journal of medicinecited by 325

PMID 6401193DOI 10.1056/nejm198301063080102PUB-06401193

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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