Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473109
Status:
COMPLETED
Last Update Posted:
2009-05-25
First Post:
2007-05-11
Brief Title:
Chronic Hemodialysis Without Systemic Heparinization a Randomized Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Chronic Hemodialysis Without Systemic Heparinization a Randomized Study
Status:
COMPLETED
Status Verified Date:
2007-05
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:
HDSH
Brief Summary:
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit However low molecular weight heparin LMWH or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications In this setting several procedures theoretically allow dialysis without systemic heparinization but randomized studies to compare them are lacking The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline rises Two emerging procedures are increasingly used continuous pre-dilution of the arterial line pre-dilution and the use of a specific dialysis membrane NEPHRAL 400 ST coated with heparin immediately before use heparin adsorption
Detailed Description:
Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit However low molecular weight heparin LMWH or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications In this setting several procedures theoretically allow dialysis without systemic heparinization but randomized studies to compare them are lacking The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline rises Two emerging procedures are increasingly used continuous pre-dilution of the arterial line pre-dilution and the use of a specific dialysis membrane NEPHRAL 400 ST coated with heparin immediately before use heparin adsorption
We propose a monocentric prospective randomized open study to compare rises pre-dilution and heparin adsorption in chronic hemodialysis patients with contra-indication to the use of LMWH Main criteria will be extra-corporeal circuit clotting with dialysis efficiency and tolerance as secondary criteria Comparison will be made on grounds of n-of-1 trial ie series of randomized cross-over tests in individuals We have planned to include 75 patients in this study with 1050 LMWH-free dialysis sessions
We hope to demonstrate chat by comparison wit rises pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50 respectively We also hope to show that heparin adsorption i better preserves membrane integrity throughout the dialysis session resulting in enhanced dialysis efficiency ii avoids extra fluid infusion and ultrafiltration resulting in better dry weigh achievement and better clinical tolerance
We propose a monocentric prospective randomized open study to compare rises pre-dilution and heparin adsorption in chronic hemodialysis patients with contra-indication to the use of LMWH Main criteria will be extra-corporeal circuit clotting with dialysis efficiency and tolerance as secondary criteria Comparison will be made on grounds of n-of-1 trial ie series of randomized cross-over tests in individuals We have planned to include 75 patients in this study with 1050 LMWH-free dialysis sessions
We hope to demonstrate chat by comparison wit rises pre-dilution and heparin absorption techniques reduce the rate of extra-corporeal circuit by 30 and 50 respectively We also hope to show that heparin adsorption i better preserves membrane integrity throughout the dialysis session resulting in enhanced dialysis efficiency ii avoids extra fluid infusion and ultrafiltration resulting in better dry weigh achievement and better clinical tolerance
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRC05032 | None | None | None |