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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Chloride | Placebo Comparator |
| |
| Desmopressin (DDAVP) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin (DDAVP) | Drug | Patients in the intervention group will receive desmopressin 0.3ug/kg administered as an intravenous infusion 1h before the proposed procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events | Incidence of bleeding related to the procedure | Immediately post-biopsy until 48 hours post-biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Incidence of major bleeding, defined as need for transfusion of blood components, need for embolization, nephrectomy or procedure-related death | Immediately post-biopsy until 48 hours post-biopsy |
| Minor bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with hyponatremia, skin reaction, anaphylaxis | Number of participants with hyponatremia, skin reaction, anaphylaxis [Safety and Tolerability] | Immediately pre-biopsy until 24 hours post-biopsy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Bauer, MD, PhD | Hospital Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90410000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39114394 | Background | Sethi J, Bansal S, Lal A, Kohli HS, Rathi M. Role of Desmopressin Acetate before Percutaneous Ultrasound-Guided Kidney Biopsy in Patients with Kidney Dysfunction. Indian J Nephrol. 2024 May-Jun;34(3):228-232. doi: 10.4103/ijn.ijn_34_23. Epub 2023 Sep 29. | |
| 32775817 | Background | Leclerc S, Nadeau-Fredette AC, Elftouh N, Lafrance JP, Pichette V, Laurin LP. Use of Desmopressin Prior to Kidney Biopsy in Patients With High Bleeding Risk. Kidney Int Rep. 2020 May 20;5(8):1180-1187. doi: 10.1016/j.ekir.2020.05.006. eCollection 2020 Aug. |
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it is not known whether there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| 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 |
|
Incidence of minor bleeding, defined as presence of macroscopic hematuria, hematoma on ultrasound 24 hours post-procedure or drop in hemoglobin greater than 20%
| Immediately post-biopsy until 48 hours post-biopsy |
| 35962638 | Background | Sattari SA, Shahoori A, Shahbazian H, Sabetnia L, Aref A, Sattari AR, Ghorbani A. Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial. Iran J Kidney Dis. 2022 Jul;16(4):238-245. |
| 21354681 | Background | Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26. |
| 6401193 | Background | Mannucci PM, Remuzzi G, Pusineri F, Lombardi R, Valsecchi C, Mecca G, Zimmerman TS. Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia. N Engl J Med. 1983 Jan 6;308(1):8-12. doi: 10.1056/NEJM198301063080102. |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |