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Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

This study has been terminated.
(run out of independent funding)
Sponsor:
Information provided by (Responsible Party):
Tibor Fulop, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00334204
First received: June 2, 2006
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

Resource links provided by NLM:

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
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Measure PFA-100
measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
 Device: measuring PFA-100 platelet function before kidney biopsy
measuring PFA-100 platelet function before kidney biopsy
Other Names:
  • in vitro platelet tests
  • platelet closure time
  • platelet function

  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.

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  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 by University of Mississippi Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tibor Fulop, Associate Professor of Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00334204     History of Changes
Other Study ID Numbers: 2004-0092
Study First Received: June 2, 2006
Last Updated: January 17, 2013
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:
Blood Platelet Disorders
Hemorrhage
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
 Hematologic Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on May 16, 2013