Trial Outcomes & Findings for Maintaining Patency in Implanted Port Catheters (NCT NCT02354118)
NCT ID: NCT02354118
Last Updated: 2022-10-12
Results Overview
Number of participants who had a first complete occlusion (Blockage) within 1 year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
436 participants
Primary outcome timeframe
baseline to 1 year
Results posted on
2022-10-12
Participant Flow
Participant milestones
| Measure |
Control Group
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
214
|
|
Overall Study
COMPLETED
|
222
|
214
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.14 years
STANDARD_DEVIATION 12.32 • n=222 Participants
|
59.30 years
STANDARD_DEVIATION 11.61 • n=214 Participants
|
59.22 years
STANDARD_DEVIATION 11.96 • n=436 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=222 Participants
|
143 Participants
n=214 Participants
|
296 Participants
n=436 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=222 Participants
|
71 Participants
n=214 Participants
|
140 Participants
n=436 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
222 participants
n=222 Participants
|
214 participants
n=214 Participants
|
436 participants
n=436 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 yearPopulation: NOTE: 1 participant had BOTH a partial occlusion and a complete occlusion. Therefore, when adding information from Outcome Measures 1 and 2 to determine the total number of participants with either complete or partial occlusions in the "Control Group" is correct as 43 (i.e., (5+39 = 44) - 1 participant in both groups = 43 distinct participants)
Number of participants who had a first complete occlusion (Blockage) within 1 year
Outcome measures
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Number of Participants With First Complete Occlusion Within 1 Year
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 yearPopulation: NOTE: 1 participant had BOTH a partial occlusion and a complete occlusion. Therefore, when adding information from Outcome Measures 1 and 2 to determine the total number of participants with either complete or partial occlusions in the "Control Group" is correct as 43 (i.e., (5+39 = 44) - 1 participant in both groups = 43 distinct participants)
Number of Participants with First Partial Occlusion (Blockage) within 1 year
Outcome measures
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Number of Participants With First Partial Occlusion Within 1 Year
|
39 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 yearNumber of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year
Outcome measures
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
|
39 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: baseline to 1 yearNumber of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year
Outcome measures
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Number of Participants With First Complete or Partial Occlusion Within 1 Year
|
43 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: baseline to 1 yearHeparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
Outcome measures
| Measure |
Control Group
n=222 Participants
Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Heparinized saline catheter flush: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
|
Intervention Group
n=214 Participants
Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Saline-only catheter flush: The intervention group will have their port catheters flushed with saline only.
|
|---|---|---|
|
Number of Participants With HIT Within 1 Year
|
0 Participants
|
0 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 42 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 27 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place