Catheter; Complications (Indwelling Catheter), Obstruction; Catheter, Infusion Catheter (Vascular)
Conditions
Brief summary
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.
Detailed description
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.
Interventions
The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
The intervention group will have their port catheters flushed with saline only.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to read and understand English * Has an implanted port in place less than one (1) year * Evidence of a patent (unobstructed) port catheter prior to enrollment in the study * Is receiving active treatment (i.e., receiving a therapeutic drug through the implanted port) * Current treatment protocol projected to continue for a minimum of three (3) months * Anticipates receiving care at the identified centers for 12 months following enrollment in the study * Does not receive care of implanted port at any other facility
Exclusion criteria
* Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin * Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin) * Does not have a BioFlo port (heparinized port) * Does not meet one or more of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Complete Occlusion Within 1 Year | baseline to 1 year | Number of participants who had a first complete occlusion (Blockage) within 1 year |
| Number of Participants With First Partial Occlusion Within 1 Year | baseline to 1 year | Number of Participants with First Partial Occlusion (Blockage) within 1 year |
| Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year | baseline to 1 year | Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Complete or Partial Occlusion Within 1 Year | baseline to 1 year | Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year |
| Number of Participants With HIT Within 1 Year | baseline to 1 year | Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 222 |
| 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. | 214 |
| Total | 436 |
Baseline characteristics
| Characteristic | Total | Control Group | Intervention Group |
|---|---|---|---|
| Age, Continuous | 59.22 years STANDARD_DEVIATION 11.96 | 59.14 years STANDARD_DEVIATION 12.32 | 59.30 years STANDARD_DEVIATION 11.61 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 436 participants | 222 participants | 214 participants |
| Sex: Female, Male Female | 296 Participants | 153 Participants | 143 Participants |
| Sex: Female, Male Male | 140 Participants | 69 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 222 | 27 / 214 |
| other Total, other adverse events | 0 / 222 | 0 / 214 |
| serious Total, serious adverse events | 0 / 222 | 0 / 214 |
Outcome results
Primary
Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year
Time frame: baseline to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year | 39 Participants |
| Intervention Group | Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year | 55 Participants |
Primary
Number of Participants With First Complete Occlusion Within 1 Year
Number of participants who had a first complete occlusion (Blockage) within 1 year
Time frame: baseline to 1 year
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With First Complete Occlusion Within 1 Year | 5 Participants |
| Intervention Group | Number of Participants With First Complete Occlusion Within 1 Year | 4 Participants |
Primary
Number of Participants With First Partial Occlusion Within 1 Year
Number of Participants with First Partial Occlusion (Blockage) within 1 year
Time frame: baseline to 1 year
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With First Partial Occlusion Within 1 Year | 39 Participants |
| Intervention Group | Number of Participants With First Partial Occlusion Within 1 Year | 55 Participants |
Secondary
Number of Participants With First Complete or Partial Occlusion Within 1 Year
Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year
Time frame: baseline to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With First Complete or Partial Occlusion Within 1 Year | 43 Participants |
| Intervention Group | Number of Participants With First Complete or Partial Occlusion Within 1 Year | 59 Participants |
Secondary
Number of Participants With HIT Within 1 Year
Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
Time frame: baseline to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With HIT Within 1 Year | 0 Participants |
| Intervention Group | Number of Participants With HIT Within 1 Year | 0 Participants |
p-value: 1Chi-squared