Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy
研究概览
简要总结
The kidneys are highly vascular organs and any trauma or surgery poses risk of severe bleeding. Platelet function is an integral part of the blood clotting during the initial, so-called vascular phase. So far no universally accepted, easy test has been available to measure platelet functions. Renal failure is a condition generally associated with bleeding due to platelet dysfunctions. This study is exploring the utility of a novel platelet function test, called Platelet Function Analyser-100 to predict bleed after percutaneous kidney biopsy. Platelet Function Analyser-100 will be measure before kidney biopsy along with routine blood tests. Subjects will undergo renal ultrasound before and after renal biopsy to verify post-biopsy bleeding events.
详细描述
Many patients with advanced chronic kidney disease have a predisposition to bleed. This predisposition becomes problematic when they have to undergo an invasive procedure such as a renal biopsy. There are multiple factors that play a role in the predisposition to bleed. These factors all cause abnormal platelet function. Historically there are several tests that have been used to assess the bleeding tendency of patients with renal disease. The most extensively studied of these is the bleeding time. Ideally this is not the best test because it is difficult to reproduce, insensitive, operator dependent and time consuming. Recognizing the limitation of the bleeding time, the Platelet Function Analyser-100 (PFA-100) was developed. This test attempts to mimic the way a clot normally forms in the body.
The purpose of this study is to determine whether an abnormal Platelet Function Analyser-100, a test which determines platelet function, is an accurate predictor of bleeding in those with chronic kidney disease.
All patients admitted for renal biopsy will be offered enrollment in this study. Initial data to include the following will be obtained: age, sex, weight, serum creatinine, activated Prothrombin Time/activated Partial Thromboplastin Time, Complete Blood Count and Platelet Function Analyser-100 closure times. Participants will then be placed in groups (cohorts) based on their calculated Glomerular Filtration Rate and if less than 30 cc/min, Desmopressin [Brand Name: DDAVP] (a drug which appears to improve platelet function) will be given. Post-procedure, participants will be monitored for bleeding by obtaining a Complete Blood Count (CBC) 4 hours and approximately 16 hours post-procedure and monitoring urine for blood. The pre- and post-procedure hematocrit and a post biopsy renal ultrasound will be used to determine whether an abnormal Platelet Function Analyser-100 closure time was predictive of a decrease in hematocrit
There are no additional risks of participation in this study. This study would only involve obtaining additional blood but it would be obtained with blood that would otherwise be obtained prior to renal biopsy. There is no direct benefit from this study to enrolled participants. Besides the Platelet Function Analyser-100 blood test, the patients undergoing renal biopsies will undergo the procedure and post-procedure monitoring per standard of care for renal biopsy at this institution.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will offer enrollment to essentially all patients undergoing standard percutaneous renal biopsy here at the University Medical Center. These are:
- •age 18-80, Body Mass Index (BMI) <35, Modification of Diet in Renal Diseases (MDRD) calculated Glomerular Filtration Rate (GFR) >10 cc/minute/1.73 m2, Hematocrit >25, platelet count >100,000/mm3, normal activated Prothrombin Time (aPT)/activated Partial Thromboplastin Time (aPTT).
排除标准
- •(essentially the contraindications to a standard percutaneous renal biopsy) known bleeding disorder, history of prior bleeding with procedure or known ongoing bleeding at the time of the procedure, Hematocrit <25, Platelet count <100, abnormal aPT/aPTT pre biopsy, small kidney(s) < 8.0 cm multiple bilateral renal cyst or masses, hydronephrosis, active urinary tract infection, recent nonsteroidal anti-inflammatory drug use.
研究组 & 干预措施
Measure Platelet Function Analyser -100 (PFA-100)
measuring Platelet Function Analyser (PFA)-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
干预措施: measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy (Device)
结局指标
主要结局
Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy
时间窗: 12 hours
Need for Blood Transfusion
时间窗: 12
Hemoglobin/Hematocrit After Biopsy
时间窗: 12 hours
次要结局
未报告次要终点
研究者
Tibor Fulop
Associate Professor of Medicine
University of Mississippi Medical Center