Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy? - Full Text View

Sponsor:	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?

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:

Bleeding after kidney biopsy on renal ultrasound 12 hours after biopsy [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
Hemoglobin/hematocrit after biopsy [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
Need for blood transfusion [ Time Frame: 12 ] [ Designated as safety issue: Yes ]

Enrollment:	58
Study Start Date:	August 2004
Study Completion Date:	December 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

measuring PFA-100 platelet function before kidney biopsy

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334204

Locations

United States, Mississippi
University of Mississipppi Medical Center, Adult Hospital
Jackson, Mississippi, United States, 39216

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators

Principal Investigator:

Tibor Fulop

University of Mississippi Medical Center, Nephrology Division

More Information

No publications provided

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:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00334204 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

PFA-100
renal failure
kidney biopsy
bleeding
hematoma

Additional relevant MeSH terms:

Renal Insufficiency
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Blood Platelet Disorders

Kidney Failure, Chronic
Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Hemorrhage
Kidney Failure

ClinicalTrials.gov processed this record on November 22, 2009