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: June 26, 2013
Last verified: June 2013
  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 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.


Condition Intervention Phase
Kidney Failure, Acute
Kidney Failure, Chronic
Blood Platelet Disorders
Hemorrhage
Device: measuring Platelet Function Analyser-100 (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:


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 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)
Device: measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy
measuring Platelet Function Analyser (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, 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).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 11, 2013
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Platelet Function Analyser-100 (PFA-100)
renal failure
kidney biopsy
bleeding
hematoma

Additional relevant MeSH terms:
Hemorrhage
Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Blood Platelet Disorders
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Hematologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014