Deep Vein ThrombosisNCT01670188
SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines
A study testing Pneumatic SCD - VenaFlow System (DJO Global) in people with Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Pneumatic SCD - VenaFlow System (DJO Global)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 13 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject's age is greater than or equal to 18 years
- Subject is patient in neuro intensive care unit at time of PICC placement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
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.
Read the 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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Pneumatic SCD - VenaFlow System (DJO Global)
- Keywords
- Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic SCD - VenaFlow System (DJO Global)Device
Also called VenaFlow System (DJO Global)
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic SCD | Active comparator | Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted. Receives: Device: Pneumatic SCD - VenaFlow System (DJO Global) |
| Non-SCD group | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
Measured: baseline to 14 days post insertion of PICC line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion13 Oct 2016
- Study completion13 Oct 2016
Why it stopped: Interim analysis: patients treated with SCD had higher incidence of DVT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Rabinstein, Mayo Clinic
- Investigators
- Alejandro Rabinstein, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670188
- Sponsor's protocol ID
- 12-004676
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2012
- Last updated
- 9 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 31236782
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients
- ClinicalTrials.gov ID
- NCT01670188
- Acronym / sponsor ID
- 12-004676
- Conditions
- Deep Vein Thrombosis
- Keywords
- Pneumatic sequential compression device (SCD), Peripherally Inserted Central Catheters (PICC)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis: patients treated with SCD had higher incidence of DVT.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 13 Oct 2016 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Posted 9 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic SCD | Active comparator | Device: Pneumatic SCD - VenaFlow System (DJO Global)Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted. |
| Non-SCD group | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject's age is greater than or equal to 18 years
- Subject is patient in neuro intensive care unit at time of PICC placement
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic SCD - VenaFlow System (DJO Global)Also: VenaFlow System (DJO Global) | Device | Pneumatic SCD |
Primary outcome
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis
Time frame: baseline to 14 days post insertion of PICC line
Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31236782Rabinstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Rabinstein, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic SCD - VenaFlow System (DJO Global) in people with Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis (time frame: baseline to 14 days post insertion of PICC line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.