Clinical Trial: Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

Brief Summary: 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.

Detailed Summary:

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 whethe
Sponsor: University of Mississippi Medical Center

Current Primary Outcome:

  • Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy [ Time Frame: 12 hours ]
  • Hemoglobin/Hematocrit After Biopsy [ Time Frame: 12 hours ]
  • Need for Blood Transfusion [ Time Frame: 12 ]


Original Primary Outcome:

  • Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy
  • Hemoglobin/Hematocrit After Biopsy
  • Need for Blood Transfusion


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Mississippi Medical Center

Dates:
Date Received: June 2, 2006
Date Started: August 2004
Date Completion:
Last Updated: June 26, 2013
Last Verified: June 2013