A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter

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:

1. Duration of catheter use (survival)
2. Reason(s) for catheter removal

Study Overview

• Status: Enrolling by invitation
• Conditions: ESRD; Acute Renal Failure; CKD; AKI - Acute Kidney Injury
• Intervention / Treatment: Device: Vascular access catheter to support dialysis or CRRT

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-954
    • Independent Public Hospital No. 4, Lublin
  • Łęczna, Poland, 21-010
    • Independent Public Health Care Unit, Łęczna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients ≥ 18 years of age at the time of catheter insertion.
• Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease [ESRD]).
• Patients who required vascular access to perform extracorporeal blood purification using GamCath HighFlow Dolphin Protect Catheter inserted by a physician in the subclavian, jugular, or femoral veins.

Exclusion Criteria:

• Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification.
• Patients who had a local infection at the vascular access site prior to catheter insertion.
• Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow Dolphin Protect Catheter placement.
• Patients who had a prior catheter in place at the same vascular access site (i.e., R/L jugular vein, R/L femoral vein, R/L subclavian vein) within the last 7 days.
• Patients who do not have complete patient records to support the primary endpoint analyses.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consecutive CKD including ESRD treatments; Consecutive retrospective treatments across all sites with a diagnosis of CKD, including ESRD	Device: Vascular access catheter to support dialysis or CRRT; A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT
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)	Device: Vascular access catheter to support dialysis or CRRT; A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT
Consecutive acute/chronic kidney disease treatments; Consecutive retrospective treatments across all sites with acute or chronic disease (excluding cases previously identified)	Device: Vascular access catheter to support dialysis or CRRT; A specialised vascular access catheter to support bi-directional blood flow at high rates to allow extracorporeal removal of toxins by dialysis or CRRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Wojciech Dąbrowski, Prof MD PhD, Independent Public Clinical Hospital No. 4, Lublin; Principal Investigator: Marek Winiarz, MD, Independent Public Health Care Unit, Łęczna

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: continuous renal replacement therapy; extracorporeal blood purification
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: BXU565389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter 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 Baxter 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 Baxter prior to the release of any data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes