Status:
WITHDRAWN
Blood Flow Effects on Silicon Substrates
Lead Sponsor:
University of California, San Francisco
Conditions:
ESRD
Eligibility:
All Genders
18-75 years
Brief Summary
This is a non-randomized, open label, uncontrolled first in human safety study, testing the the material used in the artificial kidney device in subjects already on hemodialysis. Six subjects already...
Detailed Description
For patient safety, the investigators will measure the following labs: Blood tests (routine safety and frequency). CBC/platelets: q 1 hr, at HD next day ABGs, including lactate: Q 1 hr x 6 Na, K, Cl,...
Eligibility Criteria
Inclusion
- 18-75 y/o
- ESRD on hemodialysis for at least 3 months
- HD access capable of sustaining at least 300 ml/min blood flow
- Hg \> 10.0 g
- Able to take aspirin 81 mg/day for a week prior to the study (for those subjects not already on aspirin)
- Able to read, speak and understand English
- Capable of providing signed informed consent
- HD pt at one of the UCSF outpatient HD units
Exclusion
- Subjects with active liver, cardiovascular, neurologic or psychiatric diseases
- Subjects with other active medical problems (e.g., cancer undergoing treatment)
- h/o intradialytic or orthostatic hypotension
- h/o thrombosis or on treatment for thrombosis or use of anticoagulants, excluding antiplatelet agents
- h/o active infection or on antibiotics
- h/o active autoimmune diseases or other inflammatory states
- Ongoing alcohol or illegal drug use
- Pregnant
- H/o hemolysis or allergic reactions to any dialyzers
- Anyone who in the opinion of the study doctors is not qualified to be in the study.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03241667
Start Date
July 15 2019
End Date
June 30 2020
Last Update
February 28 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.