Trial Outcomes & Findings for Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters (NCT NCT00728819)

Results Overview

Number participants with vein thrombosis

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

339 participants

Primary outcome timeframe

28 days, PICC removal or hospital discharge

Results posted on

2018-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Taper PICC Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Overall Study STARTED	171	168
Overall Study COMPLETED	135	139
Overall Study NOT COMPLETED	36	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taper PICC n=171 Participants Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC n=168 Participants Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Total n=339 Participants Total of all reporting groups
Age, Customized 18-90 yo	171 Participants n=99 Participants	168 Participants n=107 Participants	339 Participants n=206 Participants
Sex: Female, Male Female	77 Participants n=99 Participants	71 Participants n=107 Participants	148 Participants n=206 Participants
Sex: Female, Male Male	94 Participants n=99 Participants	97 Participants n=107 Participants	191 Participants n=206 Participants
Region of Enrollment United States	171 Participants n=99 Participants	168 Participants n=107 Participants	339 Participants n=206 Participants

PRIMARY outcome

Timeframe: 28 days, PICC removal or hospital discharge

Number participants with vein thrombosis

Outcome measures

Outcome measures
Measure	Taper PICC n=139 Participants Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC n=135 Participants Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Evidence of PICC-related Venous Thrombosis	102 Participants	95 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Number of participants who received the intervention as assigned

Post-operative bleeding

Outcome measures

Outcome measures
Measure	Taper PICC n=168 Participants Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC n=164 Participants Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Post-operative Bleeding	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Procedure through 28 days

Population: Number of participants who had this outcome measure

Symptomatic PICC-related venous thrombosis

Outcome measures

Outcome measures
Measure	Taper PICC n=167 Participants Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC n=164 Participants Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Symptomatic PICC-related Venous Thrombosis	6 Participants	7 Participants

Adverse Events

Taper PICC

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Non-tapered PICC

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Taper PICC n=171 participants at risk Tapered PICC Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins	Non-tapered PICC n=168 participants at risk Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Skin and subcutaneous tissue disorders Purelence	0.58% 1/171 • Number of events 1	0.60% 1/168 • Number of events 1
Infections and infestations fever	5.8% 10/171	5.4% 9/168

Additional Information

Associate Professor of Radiology

Penn Medicine

Phone: 2156627892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place