Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Bleeding After Kidney Biopsy
Study Overview
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.
Detailed Description
Kidney biopsy frequently is used to investigate the cause of suspected renal parenchymal disease. Although kidney biopsy may provide important diagnostic information and guide therapeutic decisions, the benefits must be weighed against the potential harms of biopsy. Bleeding is one of the most feared risks from a renal biopsy.
The technique has significantly evolved because of the introduction of real-time ultrasound guidance and use an automated spring-loaded biopsy device. As a consequence, the general safety and complication rate of the procedure has substantially improved. Post biopsy bleeding (hematoma and hematuria) is the primary complication of renal biopsies. However, most of the perirenal hematomas are minor and without clinical significance, and major complications are infrequent.
To minimize bleeding risk, we used the following prebiopsy parameters as a guide: prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, age, sex, glomerular filtration rate and blood pressure. Antiaggregant and anticoagulant were stopped for 7 -10 days before biopsy. The Ivy bleeding time (BT) was performed.
Although an specific lancet is used to deliver a relatively standardized incision on the patient's forearm, the Ivy bleeding time technique is patient and operator-dependent. Skin thickness varies not only with age, but also with a number of other factors, such as nutritional status. For these reasons was developed the platelet function analyzer, PFA-100. This test assess primary haemostasis in vitro using citrated whole blood. The device simulates in vivo haemostatic plug formation under high shear flow by measuring the time required to occlude (closure time, CT) a collagen/epinephrine (Coll-EPI) or collagen/ADP (Coll-ADP)-coated aperture inserted in a plastic membrane. PFA-100 is more sensitive than BT to abnormalities of primary haemostasis.
The objective of this study is to demonstrate whether an abnormal PFA-100 can predict bleeding events after percutaneous kidney biopsy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients undergoing standard percutaneous renal biopsy performed in our Unit
Exclusion Criteria
- •contraindication to standard percutaneous renal biopsy
Outcomes
Primary Outcomes
Bleeding After Kidney Biopsy
Time Frame: 24 hours
Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).
Secondary Outcomes
- Hemoglobin After Kidney Biopsy(24 hours)
Investigators
Loreto GESUALDO
Full Professor of Nephrology
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari