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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P830063 S002/ PAS001 |
| Date Original Protocol Accepted |
08/28/2002
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| Date Current Protocol Accepted |
|
| Study Name |
Gambro PAS
|
| Device Name |
GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This was an un-controlled, open study design in which patients deemed treatable by their physician with the Gambro Prisma TPE System and the Gambro Plasmafilter PF 2000N were included in the PAS.
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| Study Population |
Study population is as per device indication. The Gambro Fiber Plasmafilter PP is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulating plasma components or protein-bound toxins.
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| Sample Size |
The conditions of approval required a study of at least 400 patients from a minimum of three sites and the first 10 patients who received at least 4 treatments were to be followed for a month following these treatments.
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| Key Study Endpoints |
The data collected for each individual treatment during this post-market surveillance study should include: the patient identification number, the ordinal number of treatment, the duration of treatment, all patient complications, all device difficulties, and a brief description of the extracorporeal blood and plasma circulation system used for the therapy including manufacturer's name, model number, and operating parameters (TMP, blood flow rate, plasma flow rate, device inlet pressure, venous outlet pressure). The data should be divided into two general categories: 1) patient complications (including symptoms) and 2) difficulties experienced with the operation of the device together with a record of all alarms. Patient complications should be further divided into two sections:1. I) device-refated complications and 1.2) other complications. The section of the data concerning patient complications should include all operator interventions or responses either to the device or the patient's condition.
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| Follow-up Visits and Length of Follow-up |
1 month
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
total of 414 treatments were performed on 31 subjects at 7 centers.
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
100%
|
| Final Safety Findings |
A number of symptoms were seen at varying prevalences. Chills were most common (25% of treatments), followed by access problems (10%). Other symptoms were seen at lower frequency. All the relatively common symptoms seen were those associated with extracorporeal blood treatment generally rather than specifically with plasma filtration. A decision was made to discontinue plasmafiltration in 24 (5.8%) of the treatments. This however, was far more common when there were access problems that when there were not (88% of severe access problems, versus 4% of no access problem treatments). Clotting of the plasmafilter occurred in 6% of treatments; repeated clotting was also associated with discontinuation of the plasmafiltration. Discontinued treatments averaged 0.38 filter changes each, versus 0.04 for the treatments that were completed. Blood leaks from the plasmafilter occurred in 3 of the 414 treatments. This low rate of complications did not interfere with the ability to deliver the prescribed treatment - more than half the treatments delivered an exchange volume within 1% of that prescribed. The 414 treatments included 56 with blood access flow problems. However, only one of these was related to the Prisma TPE. There was a total of 6 unanticipated serious adverse events. None of these was fatal Three were judged 'definitely not' and the other three 'probably not' related to the study. These figures indicate that the Prisma TPE provides the required therapy effectively, and that it has a very low rate of complications.
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| Study Strengths & Weaknesses |
Strength: Sample size was larger than required. Weakness, descriptive nature. No comparison group
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| Recommendations for Labeling Changes |
None
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