Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334204
Status:
TERMINATED
Last Update Posted:
2013-08-01
First Post:
2006-06-02
Brief Title:
Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy
Sponsor:
University of Mississippi Medical Center
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
run out of independent funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Many patients with advanced chronic kidney disease have a predisposition to bleed This predisposition becomes problematic when they have to undergo an invasive procedure such as a renal biopsy There are multiple factors that play a role in the predisposition to bleed These factors all cause abnormal platelet function Historically there are several tests that have been used to assess the bleeding tendency of patients with renal disease The most extensively studied of these is the bleeding time Ideally this is not the best test because it is difficult to reproduce insensitive operator dependent and time consuming Recognizing the limitation of the bleeding time the Platelet Function Analyser-100 PFA-100 was developed This test attempts to mimic the way a clot normally forms in the body
The purpose of this study is to determine whether an abnormal Platelet Function Analyser-100 a test which determines platelet function is an accurate predictor of bleeding in those with chronic kidney disease
All patients admitted for renal biopsy will be offered enrollment in this study Initial data to include the following will be obtained age sex weight serum creatinine activated Prothrombin Timeactivated Partial Thromboplastin Time Complete Blood Count and Platelet Function Analyser-100 closure times Participants will then be placed in groups cohorts based on their calculated Glomerular Filtration Rate and if less than 30 ccmin Desmopressin Brand Name DDAVP a drug which appears to improve platelet function will be given Post-procedure participants will be monitored for bleeding by obtaining a Complete Blood Count CBC 4 hours and approximately 16 hours post-procedure and monitoring urine for blood The pre- and post-procedure hematocrit and a post biopsy renal ultrasound will be used to determine whether an abnormal Platelet Function Analyser-100 closure time was predictive of a decrease in hematocrit
There are no additional risks of participation in this study This study would only involve obtaining additional blood but it would be obtained with blood that would otherwise be obtained prior to renal biopsy There is no direct benefit from this study to enrolled participants Besides the Platelet Function Analyser-100 blood test the patients undergoing renal biopsies will undergo the procedure and post-procedure monitoring per standard of care for renal biopsy at this institution
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 Index35 Modification of Diet in Renal Diseases DMDRDformula-based calculated Glomerualar Filtration Rate GFR10ccminute Hematocrit 25 platelet count 100 normal aPTaPTT
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 activated Prothrombin Time aPTactivated Partial Thromboplastin Time aPTT pre biopsy small kidneys 80 cm multiple bilateral renal cyst or masses hydronephrosis active urinary tract infection recent nonsteroidal anti-inflammatory drug use
Risk
The Platelet Function Analyser 100 will require an additional 5-10cc of blood to be drawn No additional sticks will be done since generally prior to biopsy the patients will have Complete Blood Count aPTaPTT and chemistries drawn
Possible benefits to patients
There will likely be no benefit for the individual patient The Platelet Function Analyser 100 is a relatively new test for determining platelet dysfunction and there have been limited studies in dialysis patients However to date there have been no studies in those with chronic kidney disease If a correlation is found between an abnormal Platelet Function Analyser and bleeding instead of giving all patients with compromised Glomerular Filtration Rate desmopressin only those with abnormal Platelet Function Analyser would be given desmopressin In essence this would decrease the patient incurred expenses of hospitalization This test may also point out those patients who are high risk for bleed post renal biopsy and may ultimately alter length of in hospital monitoring of patients post biopsy
Other benefit of this test is that it is a noninvasive rapid and does not require specialized training to perform the test
Alternatives
In lieu of checking Platelet Function Analyser 100 a bleeding time could be done but it has been demonstrated in multiple studies to poorly correlate with bleeding The results for bleeding time often vary because it is a difficult test to reproduce Currently there is no standard or acceptable pre-renal biopsy platelet function test done at this Institution
Consent process
The patient who will be enrolled in this study have already agreed to undergo a renal biopsy which will be the reason for their hospital admission They will be allowed to discuss with family members via phone or if they are present at the hospital but it will not be feasible for patients to be allowed to take the consent home and defer biopsy for discussion
The investigator will have a discussion about the Platelet Function Analyser 100 with all prospective participants prior to renal biopsy being performed The discussion will include the risks and benefits of having the test performed The patients will be allowed to ask questions If consent is given then the Platelet Function Analyser-100 will be drawn
Cost
There will be no significant increase in cost The reagent used to do the test is being donated and the Department of Pathology is willing to do the test without any additional charge to the patient
Compensation to participants none
Data preservation and analysis
The data obtained during this study will only be available to the Principal investigator and immediate study personnel
The data will be kept by the Principal investigator in a secured location indefinitely
The results of the Platelet Function Analyser testings will be in the medical record with the result of the other labs obtained during hospitalization
The purpose of this study is to determine whether an abnormal Platelet Function Analyser-100 a test which determines platelet function is an accurate predictor of bleeding in those with chronic kidney disease
All patients admitted for renal biopsy will be offered enrollment in this study Initial data to include the following will be obtained age sex weight serum creatinine activated Prothrombin Timeactivated Partial Thromboplastin Time Complete Blood Count and Platelet Function Analyser-100 closure times Participants will then be placed in groups cohorts based on their calculated Glomerular Filtration Rate and if less than 30 ccmin Desmopressin Brand Name DDAVP a drug which appears to improve platelet function will be given Post-procedure participants will be monitored for bleeding by obtaining a Complete Blood Count CBC 4 hours and approximately 16 hours post-procedure and monitoring urine for blood The pre- and post-procedure hematocrit and a post biopsy renal ultrasound will be used to determine whether an abnormal Platelet Function Analyser-100 closure time was predictive of a decrease in hematocrit
There are no additional risks of participation in this study This study would only involve obtaining additional blood but it would be obtained with blood that would otherwise be obtained prior to renal biopsy There is no direct benefit from this study to enrolled participants Besides the Platelet Function Analyser-100 blood test the patients undergoing renal biopsies will undergo the procedure and post-procedure monitoring per standard of care for renal biopsy at this institution
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 Index35 Modification of Diet in Renal Diseases DMDRDformula-based calculated Glomerualar Filtration Rate GFR10ccminute Hematocrit 25 platelet count 100 normal aPTaPTT
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 activated Prothrombin Time aPTactivated Partial Thromboplastin Time aPTT pre biopsy small kidneys 80 cm multiple bilateral renal cyst or masses hydronephrosis active urinary tract infection recent nonsteroidal anti-inflammatory drug use
Risk
The Platelet Function Analyser 100 will require an additional 5-10cc of blood to be drawn No additional sticks will be done since generally prior to biopsy the patients will have Complete Blood Count aPTaPTT and chemistries drawn
Possible benefits to patients
There will likely be no benefit for the individual patient The Platelet Function Analyser 100 is a relatively new test for determining platelet dysfunction and there have been limited studies in dialysis patients However to date there have been no studies in those with chronic kidney disease If a correlation is found between an abnormal Platelet Function Analyser and bleeding instead of giving all patients with compromised Glomerular Filtration Rate desmopressin only those with abnormal Platelet Function Analyser would be given desmopressin In essence this would decrease the patient incurred expenses of hospitalization This test may also point out those patients who are high risk for bleed post renal biopsy and may ultimately alter length of in hospital monitoring of patients post biopsy
Other benefit of this test is that it is a noninvasive rapid and does not require specialized training to perform the test
Alternatives
In lieu of checking Platelet Function Analyser 100 a bleeding time could be done but it has been demonstrated in multiple studies to poorly correlate with bleeding The results for bleeding time often vary because it is a difficult test to reproduce Currently there is no standard or acceptable pre-renal biopsy platelet function test done at this Institution
Consent process
The patient who will be enrolled in this study have already agreed to undergo a renal biopsy which will be the reason for their hospital admission They will be allowed to discuss with family members via phone or if they are present at the hospital but it will not be feasible for patients to be allowed to take the consent home and defer biopsy for discussion
The investigator will have a discussion about the Platelet Function Analyser 100 with all prospective participants prior to renal biopsy being performed The discussion will include the risks and benefits of having the test performed The patients will be allowed to ask questions If consent is given then the Platelet Function Analyser-100 will be drawn
Cost
There will be no significant increase in cost The reagent used to do the test is being donated and the Department of Pathology is willing to do the test without any additional charge to the patient
Compensation to participants none
Data preservation and analysis
The data obtained during this study will only be available to the Principal investigator and immediate study personnel
The data will be kept by the Principal investigator in a secured location indefinitely
The results of the Platelet Function Analyser testings will be in the medical record with the result of the other labs obtained during hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None