|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 August 2016 |
|
Main ID: |
NCT02868697 |
|
Date of registration:
|
28/06/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar
|
|
Scientific title:
|
Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar |
|
Date of first enrolment:
|
November 2013 |
|
Target sample size:
|
170 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02868697 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Qatar
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 1- Adult patients aged>14 years 2- Undergoing HD through tunneled HD 3- Recently
inserted or old tunneled catheter 4- Blood flow rate at the beginning of the study=
300ml/min
Exclusion Criteria:
- 1- Malfunctioning catheter defined by blood flow rate < 300ml/min 2- Known patient to
have allergy to drug medication 3- Major Hemorrhage in previous 4 week
Age minimum:
14 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemodialysis, Tunneled Catheter, Qatar
|
|
Intervention(s)
|
|
Drug: TauroLock U 25000
|
|
Drug: (TauroLock Hep500)
|
|
Primary Outcome(s)
|
|
Number of catheter thrombosis episodes
[Time Frame: 6 months per patient]
|
|
Secondary Outcome(s)
|
|
Amount of r-TPA used in each group for treatment of acute catheter thrombosis
[Time Frame: 6 months]
|
|
Hospitalization days related to catheter malfunctioning or CRI in each group
[Time Frame: 6 months]
|
|
Number of catheter exchange in each group
[Time Frame: 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|