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| Sponsored by: |
University of Mississippi Medical Center |
|---|---|
| Information provided by: | University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT00334204 |
Purpose
-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 PFA-100 to predict bleed after percutaneous kidney biopsy. PFA-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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure, Acute Kidney Failure, Chronic Blood Platelet Disorders Hemorrhage |
Device: measuring PFA-100 platelet function before kidney biopsy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy? |
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Will offer enrollment to essentially all patients undergoing standard percutaneous renal biopsy here at the University Medical Center. These are:
age 18-80, BMI<35, MDRD calculated GFR >10cc/minute, Hematocrit >25, platelet count >100, normal aPT/aPTT.
Exclusion Criteria:
(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.
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Contacts and Locations| Contact: Tibor Fulop, M.D. | 601 984-2889 | tfulop@medicine.umsmed.edu |
| United States, Mississippi | |
| University of Mississipppi Medical Center, Adult Hospital | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Principal Investigator: Tibor Fulop, M.D. | |
| Principal Investigator: | Tibor Fulop | University of Mississippi Medical Center, Nephrology Division |
More Information
| Responsible Party: | University of Mississippi Medical Center, Jackson, MS ( Tibor Fulop, M.D. ) |
| Study ID Numbers: | 2004-0092 |
| Study First Received: | June 2, 2006 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00334204 |
| Health Authority: | United States: Institutional Review Board |
|
PFA-100 renal failure kidney biopsy bleeding hematoma |
|
Renal Insufficiency Hematologic Diseases Blood Platelet Disorders Kidney Failure, Chronic Hemorrhage Hematoma Thrombocytopathy |
Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Kidney Failure |
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Pathologic Processes |
