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Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

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ClinicalTrials.gov Identifier: NCT00334204
Recruitment Status : Terminated (run out of independent funding)
First Posted : June 6, 2006
Results First Posted : August 1, 2013
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Tibor Fulop, University of Mississippi Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Kidney Failure, Acute
Kidney Failure, Chronic
Blood Platelet Disorders
Hemorrhage
Intervention Device: measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy
Enrollment 58
Recruitment Details 58 parcicipant recruited, 2 excluded due to missing data from analysis
Pre-assignment Details  
Arm/Group Title Measure PFA-100
Hide Arm/Group Description measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Period Title: Overall Study
Started 58
Completed 56
Not Completed 2
Arm/Group Title Measure PFA-100
Hide Arm/Group Description measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
43.68  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
21
  37.5%
Male
35
  62.5%
1.Primary Outcome
Title Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy
Hide Description [Not Specified]
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Measure PFA-100
Hide Arm/Group Description:
measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants with hematoma
11
2.Primary Outcome
Title Hemoglobin/Hematocrit After Biopsy
Hide Description [Not Specified]
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Measure Platelet Function Analyser-100 (PFA-100)
Hide Arm/Group Description:
measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants with hematuria
5
3.Primary Outcome
Title Need for Blood Transfusion
Hide Description [Not Specified]
Time Frame 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Measure Platelet Function Analyser-100 (PFA-100)
Hide Arm/Group Description:
measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants requiring PRBC Transfusion
4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Measure PFA-100
Hide Arm/Group Description measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
All-Cause Mortality
Measure PFA-100
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Measure PFA-100
Affected / at Risk (%)
Total   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Measure PFA-100
Affected / at Risk (%)
Total   0/56 (0.00%) 
Early termination leading to lesser-than-planned numbers of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tibor Fulop, M.D./Associate Professor of Medicine
Organization: University of Mississippi
Phone: 601 984-5670
EMail: tfulop@umc.edu
Layout table for additonal information
Responsible Party: Tibor Fulop, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00334204     History of Changes
Other Study ID Numbers: 2004-0092
First Submitted: June 2, 2006
First Posted: June 6, 2006
Results First Submitted: April 11, 2013
Results First Posted: August 1, 2013
Last Update Posted: August 1, 2013