Clinical trial NCT01670188: SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines
Official title: Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: Pneumatic sequential compression device (SCD)
Peripherally Inserted Central Catheters (PICC)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
timeFrame: baseline to 14 days post insertion of PICC line
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alejandro Rabinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rabinstein AA, Hellickson JD, Macedo TA, Lewis BD, Mandrekar J, McBane RD 2nd. Sequential Pneumatic Compression in the Arm in Neurocritical Patients with a Peripherally Inserted Central Venous Catheter: A Randomized Trial. Neurocrit Care. 2020 Feb;32(1):187-192. doi: 10.1007/s12028-019-00765-w.