Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies (BRIDGE)

Hospital de Clinicas de Porto Alegre

Status and phase: Invitation-only; Phase 4

Conditions: Desmopressin; Transplant, Kidney; Kidney Biopsy; Bleeding

Treatments: Drug: Desmopressin (DDAVP); Drug: Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06622187

2024-0270

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

96 participants in 2 patient groups, including a placebo group

Sodium Chloride

Placebo Comparator group

Treatment:

Drug: Sodium Chloride

Desmopressin (DDAVP)

Experimental group

Treatment:

Drug: Desmopressin (DDAVP)