Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194181
Status:
TERMINATED
Last Update Posted:
2006-07-17
First Post:
2005-09-12
Brief Title:
Rt-PA Infusion Versus Catheter Exchange for Dialysis Catheter Malfunction Due to Fibrin Sheath
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Randomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation
Status:
TERMINATED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treating central venous dialysis catheter malfunction due to fibrin sheath formation with rt-PATPAinfusion will give equal patency rates in a more cost effective manner when compared to catheter exchange
Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter function at the post treatment dialysis session 30-day dialysis session and 60-day dialysis session Costs and treatment results will be compared
Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter function at the post treatment dialysis session 30-day dialysis session and 60-day dialysis session Costs and treatment results will be compared
Detailed Description:
Patients who come to the Hospital of the University of Pennsylvania Presbyterian Medical Center or American Access in Northeast Philadelphia with a dialysis catheter thats not functioning well will be screened for this study
If the patient qualifies and consents to participate an envelope will be opened that tells us to exchange the catheter for a new one OR infuse TPA clot-dissolving drug into the 2 ports for two and a half hours Some dialysis patients have had a TPA dwell at the dialysis clinic to help increase blood flow during dialysis The motion of the infusion of TPA is expected to be more effective than a dwell that sits still Also there is more TPA used during infusion than during the dwell
Once the catheter is functioning the patient goes home as usual and follow-up is done by phone after the next dialysis session at 30 days and at 60 days Follow-up is done to check for flow rates during dialysis and to check for any problems related to the catheter treatment Participation is complete after the 60-day follow-up phone call
If the patient qualifies and consents to participate an envelope will be opened that tells us to exchange the catheter for a new one OR infuse TPA clot-dissolving drug into the 2 ports for two and a half hours Some dialysis patients have had a TPA dwell at the dialysis clinic to help increase blood flow during dialysis The motion of the infusion of TPA is expected to be more effective than a dwell that sits still Also there is more TPA used during infusion than during the dwell
Once the catheter is functioning the patient goes home as usual and follow-up is done by phone after the next dialysis session at 30 days and at 60 days Follow-up is done to check for flow rates during dialysis and to check for any problems related to the catheter treatment Participation is complete after the 60-day follow-up phone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None