Bleeding, Transplant, Kidney, Desmopressin, Kidney Biopsy
Conditions
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.
Interventions
Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure
DRUGSodium Chloride
Patients in the control group will receive sodium chloride 0.9% 100mL administered as an intravenous infusion 1h before the proposed procedure
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding events | Immediately post-biopsy until 48 hours post-biopsy | Incidence of bleeding related to the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with hyponatremia, skin reaction, anaphylaxis | Immediately pre-biopsy until 24 hours post-biopsy | Number of participants with hyponatremia, skin reaction, anaphylaxis \[Safety and Tolerability\] |
Countries
Brazil
Outcome results
None listed