Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy
1 other identifier
observational
250
1 country
1
Brief Summary
Kidney biopsy represents the criterion standard to obtain information on diagnosis and prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to bleed, especially when they undergo an invasive procedure such as renal biopsy. The predominant factor is abnormal platelet function. Therefore, the aim of this study is to evaluate whether the platelet function analyzer (PFA-100), a very reliable test to investigate primary hemostasis, can be useful in predicting the risk of bleeding complications in patients undergoing renal biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJune 18, 2019
June 1, 2019
18 days
December 2, 2018
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding After Kidney Biopsy
Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).
24 hours
Secondary Outcomes (1)
Hemoglobin After Kidney Biopsy
24 hours
Eligibility Criteria
The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of native kidney in the Department of Emergency and Organ Transplantation, the University of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded from this study.
You may qualify if:
- all patients undergoing standard percutaneous renal biopsy performed in our Unit
You may not qualify if:
- contraindication to standard percutaneous renal biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Barilead
- Prof. Carlo Mannocollaborator
- Dott. Francesco Pescecollaborator
- Dott. Michele Rossinicollaborator
- Dott. Vincenzo Di Leocollaborator
Study Sites (1)
AOUConsorziale Policlinico Di Bari
Bari, 70124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Nephrology
Study Record Dates
First Submitted
December 2, 2018
First Posted
December 4, 2018
Study Start
June 13, 2019
Primary Completion
July 1, 2019
Study Completion
September 1, 2019
Last Updated
June 18, 2019
Record last verified: 2019-06