Trial Outcomes & Findings for Blood Sampling Functionality of Extended Dwell Catheters (NCT NCT04409418)

Results Overview

Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

During hospitalization, up to 30 days

Results posted on

2024-11-15

Participant Flow

100 were consented. Prior to randomization, 9 patients were excluded for inadequate vessel size, 2 patients withdrew from the study, 1 patient investigator removed due to other IV access. 20 patients originally assigned to the forearm group crossed over to the upper arm group because there was no suitable target vessel, leaving 24 in the forearm group and 64 in the upper arm group.

Participant milestones

Participant milestones
Measure	Experimental Group If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Overall Study STARTED	24	64
Overall Study COMPLETED	24	64
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

Baseline characteristics by cohort
Measure	Experimental Group n=24 Participants If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group n=64 Participants Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Total n=88 Participants Total of all reporting groups
Age, Customized <=25 years	2 Participants n=24 Participants	1 Participants n=64 Participants	3 Participants n=88 Participants
Age, Customized 26-50 years	4 Participants n=24 Participants	14 Participants n=64 Participants	18 Participants n=88 Participants
Age, Customized 51-75 years	13 Participants n=24 Participants	34 Participants n=64 Participants	47 Participants n=88 Participants
Age, Customized >75 years	5 Participants n=24 Participants	15 Participants n=64 Participants	20 Participants n=88 Participants
Sex: Female, Male Female	11 Participants n=24 Participants	39 Participants n=64 Participants	50 Participants n=88 Participants
Sex: Female, Male Male	13 Participants n=24 Participants	25 Participants n=64 Participants	38 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 participants n=24 Participants	64 participants n=64 Participants	88 participants n=88 Participants

PRIMARY outcome

Timeframe: During hospitalization, up to 30 days

Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.

Outcome measures

Outcome measures
Measure	Experimental Group n=24 Participants If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group n=64 Participants Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Blood Sampling Functionality	70.19 hours Standard Deviation 61.41	112.9 hours Standard Deviation 141.47

SECONDARY outcome

Timeframe: During hospitalization, up to 30 days

Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of hours until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization.

Outcome measures

Outcome measures
Measure	Experimental Group n=24 Participants If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group n=64 Participants Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Catheter Dwell Time/Survival	74.27 hours Standard Deviation 59.9	115.52 hours Standard Deviation 140.42

SECONDARY outcome

Timeframe: During hospitalization, up to 30 days

The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.

Outcome measures

Outcome measures
Measure	Experimental Group n=24 Participants If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group n=64 Participants Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Thrombosis	2 Participants	5 Participants

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Group n=24 participants at risk If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.	Control Group n=64 participants at risk Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Product Issues Catheter occlusion	12.5% 3/24 • Number of events 3 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	20.3% 13/64 • Number of events 13 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Skin and subcutaneous tissue disorders Infiltration	4.2% 1/24 • Number of events 1 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	4.7% 3/64 • Number of events 3 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Product Issues Catheter dislodgement	4.2% 1/24 • Number of events 1 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	4.7% 3/64 • Number of events 3 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Product Issues Catheter leakage	4.2% 1/24 • Number of events 1 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	3.1% 2/64 • Number of events 2 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Vascular disorders Superficial vein thrombosis	8.3% 2/24 • Number of events 2 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	6.2% 4/64 • Number of events 4 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Vascular disorders Deep vein thrombosis	0.00% 0/24 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days	1.6% 1/64 • Number of events 1 • During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days

Additional Information

Dr. Amit Bahl

William Beaumont Hospitals

Phone: 248 898-9111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place