Trial Outcomes & Findings for Once Weekly Subcutaneous Ports for the Administration of Anticoagulants (NCT NCT00774748)

Results Overview

Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

approximately 3 months

Results posted on

2017-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Insuflon All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Insuflon All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insuflon n=21 Participants All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 3 months

Population: Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure.

Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants Both dosing schedules, once and twice daily, all participants.
Average Subcutaneous Anti-Xa Blood Levels	1.43 IU/mL Interval 1.41 to 1.56

SECONDARY outcome

Timeframe: 6 time points (for each participant) in approximately 3 months

Population: All participants were represented with a baseline fluctuation in percent difference.

Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.

Outcome measures

Outcome measures
Measure	All Participants n=21 Participants Both dosing schedules, once and twice daily, all participants.
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels	12 Percent Interval 1.4 to 35.6

SECONDARY outcome

Timeframe: approximately 3 months

Population: Twenty participants, excluding one outlier of 97%.

Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants Both dosing schedules, once and twice daily, all participants.
Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port	14 Percent Interval 0.0 to 68.0

SECONDARY outcome

Timeframe: 7 days

Population: All participants, excluding two outliers of 97% and 150%

Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Both dosing schedules, once and twice daily, all participants.
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7	16 Percent Interval 1.5 to 65.0

SECONDARY outcome

Timeframe: 6 time points in approximately 3 months

Population: Included all participants who had at lease one visit and one blood draw.

GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.

Outcome measures

Outcome measures
Measure	All Participants n=21 Participants Both dosing schedules, once and twice daily, all participants.
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)	6.75 mL/min Interval 0.0 to 13.5

Adverse Events

Insuflon

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insuflon n=21 participants at risk All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
Blood and lymphatic system disorders Subject had a recurrent deep vein thrombosis	4.8% 1/21 • Number of events 1

Additional Information

Clinical Research Coordinator

UNC Chapel Hill School of Medicine Dept. Hematology

Phone: 919-966-2359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place