Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

NCT00334204 | Terminated Phase 4 Results

• 1 other identifier: 2004-0092
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Acute; Kidney Failure, Chronic; Blood Platelet Disorders; Hemorrhage

Keywords

Platelet Function Analyser-100 (PFA-100); renal failure; kidney biopsy; bleeding; hematoma

Outcome Measures

Primary Outcomes (3)

• Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy

  12 hours

• Hemoglobin/Hematocrit After Biopsy

  12 hours

• Need for Blood Transfusion

  12

Study Arms (1)

Measure Platelet Function Analyser -100 (PFA-100)

OTHER

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

Interventions

measuring Platelet Function Analyser-100 (PFA-100) platelet function before kidney biopsy DEVICE

measuring Platelet Function Analyser (PFA) -100 platelet function before kidney biopsy

Also known as: in vitro platelet tests, platelet closure time, platelet function

Measure Platelet Function Analyser -100 (PFA-100)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississipppi Medical Center, Adult Hospital

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Islam N, Fulop T, Zsom L, Miller E, Mire CD, Lebrun CJ, Schmidt DW. Do platelet function analyzer-100 testing results correlate with bleeding events after percutaneous renal biopsy? Clin Nephrol. 2010 Mar;73(3):229-37. doi: 10.5414/cnp73229.

  PMID: 20178723 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic; Blood Platelet Disorders; Hemorrhage; Renal Insufficiency; Hematoma

Interventions

Platelet Function Tests

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Limitations and Caveats

Early termination leading to lesser-than-planned numbers of subjects analyzed

Results Point of Contact

• Title: Tibor Fulop, M.D./Associate Professor of Medicine
• Organization: University of Mississippi

tfulop@umc.edu

601 984-5670

Study Officials

• Tibor Fulop

  University of Mississippi Medical Center, Nephrology Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: August 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 1, 2013
• Results First Posted: August 1, 2013

Record last verified: 2013-06

Locations

US (1)