Trial Outcomes & Findings for PICC Asymptomatic Thrombosis Study: A Pilot Study (NCT NCT04920929)

NCT ID: NCT04920929

Last Updated: 2022-11-29

Results Overview

Rate of asymptomatic thrombosis measured using ultrasound technology for each group

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 7 days post insertion
• Results posted on: 2022-11-29

Participant Flow

Participant milestones

Measure	Hydrophilic BioMaterial Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PICC Asymptomatic Thrombosis Study: A Pilot Study

Baseline characteristics by cohort

Measure	Hydrophilic BioMaterial n=3 Participants Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane n=4 Participants TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material	Total n=7 Participants Total of all reporting groups
Age, Continuous	65.0 Years STANDARD_DEVIATION 14.24 • n=5 Participants	63.3 Years STANDARD_DEVIATION 2.28 • n=7 Participants	63.6 Years STANDARD_DEVIATION 9.48 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days post insertion

Population: number of subjects with asymptomatic thrombosis measured at Day 7 post insertion using ultrasound technology

Rate of asymptomatic thrombosis measured using ultrasound technology for each group

Outcome measures

Measure	Hydrophilic BioMaterial n=3 Participants Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane n=4 Participants TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material
Asymptomatic Thrombosis Rate	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days post insertion

Population: number of subjects with symptomatic thrombosis measured using ultrasound technology at day 14

Rate of symptomatic thrombosis measured using ultrasound technology

Outcome measures

Measure	Hydrophilic BioMaterial n=3 Participants Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane n=4 Participants TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material
Symptomatic Thrombosis Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 days post insertion

Population: number of subjects with symptomatic thrombosis measured with ultrasound technology at day 7

Rate of symptomatic thrombosis measured using ultrasound technology

Outcome measures

Measure	Hydrophilic BioMaterial n=3 Participants Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane n=2 Participants TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material
Symptomatic Thrombosis Rate	0 Participants	0 Participants

Adverse Events

Hydrophilic BioMaterial

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Thermoplastic Polyurethane

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hydrophilic BioMaterial n=3 participants at risk Hydrophilic BioMaterial- HydroPICC Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial	Thermoplastic Polyurethane n=4 participants at risk TPU- 4 French Single Lumen PowerPICC Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material
Vascular disorders superficial venous thrombosis of arm	66.7% 2/3 • Number of events 2 • Approximately 3 Months	25.0% 1/4 • Number of events 1 • Approximately 3 Months
Gastrointestinal disorders left lower quadrant pain	33.3% 1/3 • Number of events 1 • Approximately 3 Months	0.00% 0/4 • Approximately 3 Months
Respiratory, thoracic and mediastinal disorders lung Nodule	33.3% 1/3 • Number of events 1 • Approximately 3 Months	0.00% 0/4 • Approximately 3 Months
Vascular disorders deep venous thrombosis arm	33.3% 1/3 • Number of events 1 • Approximately 3 Months	0.00% 0/4 • Approximately 3 Months

Additional Information

Brian Hanley

Access Vascular Inc.

Phone: 1-781-538-6594

Email: bhanley@accessvascularinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60