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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
The main questions to answer are:
The objective of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter related to the duration of use (catheter survival) throughout its lifetime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive CKD including ESRD treatments | Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD |
| |
| Consecutive treatments with minimum hospital stay of 20 days | Consecutive retrospective treatments across all sites with a minimum hospital stay of days (excluding cases previously identified; may be acute or chronic disease) |
| |
| Consecutive acute/chronic kidney disease treatments | Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular access catheter to support dialysis or CRRT | Device | A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Survival | Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data | From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks |
| Reason(s) for Catheter Removal | Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance | Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Collect real-world use data describing adverse events potentially related to the study catheter or catheter insertion/removal procedures | From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Data will be collected from records of adult patients in whom the GamCath HighFlow Dolphin Protect Catheter was inserted as a vascular access to perform extracorporeal blood purification from 2018 to most recent.
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| Name | Affiliation | Role |
|---|---|---|
| Wojciech Dąbrowski, Prof MD PhD | Independent Public Clinical Hospital No. 4, Lublin | Principal Investigator |
| Marek Winiarz, MD | Independent Public Health Care Unit, Łęczna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Public Hospital No. 4, Lublin | Lublin | 20-954 | Poland | |||
| Independent Public Health Care Unit, Łęczna |
The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP). Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Łęczna |
| 21-010 |
| Poland |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |