SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-10-13

Brief Summary

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The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.

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Detailed Description

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In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group.

Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement.

Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pneumatic SCD

Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.

Group Type ACTIVE_COMPARATOR

Pneumatic SCD - VenaFlow System (DJO Global)

Intervention Type DEVICE

Non-SCD group

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pneumatic SCD - VenaFlow System (DJO Global)

Intervention Type DEVICE

Other Intervention Names

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VenaFlow System (DJO Global)

Eligibility Criteria

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Inclusion Criteria

* Subject's age is greater than or equal to 18 years
* Subject is patient in neuro intensive care unit at time of PICC placement

Exclusion Criteria

* Acute trauma to the upper extremity harboring the PICC
* Current use of prophylactic anticoagulation
* Inability to fit the SCD on the arm because of arm size
* Documented previous upper extremity DVT in the arm harboring the PICC line

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No