Pneumatic Compression for Preventing Venous Thromboembolism

Conditions

Deep Venous Thrombosis

Keywords

Deep Vein Thrombosis, Pulmonary Embolism, Intermittent Pneumatic Compression, Pharmacologic DVT, Prophylaxis, Critically Ill Patients.

Brief summary

Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.

Detailed description

There is no randomized controlled trial examining effect of the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis (UFH, LMWH) alone in critically ill patients for VTE prevention.

Al-Dorzi HM, Arishi H, Al-Hameed FM, Burns KEA, Mehta S, Jose J, Alsolamy SJ, Abdukahil SAI, Afesh LY, Alshahrani MS, Mandourah Y, Almekhlafi GA, Almaani M, Al Bshabshe A, Finfer S, Arshad Z, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Lababidi H, Al Aithan A, Al-Dawood A, Arabi YM, Saudi Critical Care Trials Group.

2024-09-023 citations

10.1016/j.chest.2024.07.182

Association of early mobility with the incidence of deep-vein thrombosis and mortality among critically ill patients: a post hoc analysis of PREVENT trial

Hasan M. Al‐Dorzi, Samah AlQahtani, Abdulaziz Al‐Dawood, Fahad Al-Hameed, Karen E. A. Burns et al. (26 authors)

Critical Care2023-03-039 citations

10.1186/s13054-023-04333-9

The effect of intermittent pneumatic compression on deep-vein thrombosis and ventilation-free days in critically ill patients with heart failure.

Al-Dorzi HM, Al-Dawood A, Al-Hameed FM, Burns KEA, Mehta S, Jose J, Alsolamy S, Abdukahil SAI, Afesh LY, Alshahrani MS, Mandourah Y, Almekhlafi GA, Almaani M, Al Bshabshe A, Finfer S, Arshad Z, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Lababidi H, Al Aithan A, Arabi YM.

2022-05-202 citations

10.1038/s41598-022-12336-9

Surveillance or no surveillance ultrasonography for deep vein thrombosis and outcomes of critically ill patients: a pre-planned sub-study of the PREVENT trial.

Arabi YM, Burns KEA, Alsolamy SJ, Alshahrani MS, Al-Hameed FM, Arshad Z, Almaani M, Hawa H, Mandourah Y, Almekhlafi GA, Al Aithan A, Khalid I, Rifai J, Rasool G, Abdukahil SAI, Jose J, Afesh LY, Al-Dawood A, Saudi Critical Care Trials Group.

2020-02-2414 citations

10.1007/s00134-019-05899-1

Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis

Yaseen M. Arabi, Fahad Al-Hameed, Karen E. A. Burns, Sangeeta Mehta, Sami Alsolamy et al. (23 authors)

New England Journal of Medicine2019-02-18210 citations

10.1056/nejmoa1816150

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

Arabi Y, Al-Hameed F, Burns KEA, Mehta S, Alsolamy S, Almaani M, Mandourah Y, Almekhlafi GA, Al Bshabshe A, Finfer S, Alshahrani M, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Arshad Z, Lababidi H, Al Aithan A, Jose J, Abdukahil SAI, Afesh LY, Dbsawy M, Al-Dawood A, PREVENT trial Group.

2018-03-1510 citations

10.1186/s13063-018-2534-6

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial.

Arabi YM, Alsolamy S, Al-Dawood A, Al-Omari A, Al-Hameed F, Burns KE, Almaani M, Lababidi H, Al Bshabshe A, Mehta S, Al-Aithan AM, Mandourah Y, Almekhlafi G, Finfer S, Abdukahil SA, Afesh LY, Dbsawy M, Sadat M.

2016-08-0313 citations

10.1186/s13063-016-1520-0

Interventions

DEVICEpneumatic compression

All IPC devices intended for DVT prophylaxis are acceptable in the study. Sequential devices (cuffs have several chambers) are preferred, but non-sequential (cuffs have single chambers) are acceptable.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

No

Inclusion criteria

A. Medical-Surgical ICU patients \>14 years old at participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) B. Weight \> 45kg C. Expected ICU LOS\> 72hrs D. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH.

Exclusion criteria

A. Patient treated with IPC for \> 24 hours in this current ICU admission. B. Patient in the ICU\> 48 hours. C. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH. D. Inability or contraindication to applying IPC to both legs i.Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement ii. Acute ischemia in the lower extremities iii. Amputated foot or leg on one or two sides iv. Compartment Syndrome v. Severe peripheral arterial disease vi. Vein ligation, gangrene, recent vein grafts, and draining incisions vii. Evidence of bone fracture in lower extremities E. Therapeutic dose of anticoagulation with UFH or LMWH F. Pregnancy G. Limitation of life support, life expectancy \< 7 days or palliative care H. Allergy to the sleeves material I. Patients with Inferior Vena Cava (IVC) Filter

Design outcomes

Primary

Measure	Time frame	Description
Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound	28 days from randomization	The primary outcome is incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge or day 28 post randomization

Secondary

Measure	Time frame	Description
Pulmonary Embolism	from the time of randomization to 90 days	Pulmonary Embolism: will be followed up to ICU discharge or day 28 post randomization. ICU Mortality. Death in ICU during the same ICU admission. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 28-day Mortality: Death before or at day 28 of enrollment. 90-day Mortality: Death before or at day 90 of enrollment.

Other

Measure	Time frame	Description
ICU Length of stay and duration of mechanical ventilation	Number of days in ICU with an average expected duration of 10 days and number of days of mechanical ventillation with an expected average duration of 8 days.	ICU Length of stay: Number of calendar days between admission and discharge from ICU. Duration of mechanical ventilation: Number of calendar days between start and end of mechanical ventilation.

Countries

Saudi Arabia

Outcome results

None listed