Pneumatic Compression for Preventing Venous Thromboembolism

NCT02040103 | Completed

• 1 other identifier: RC12-045
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound

  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

  28 days from randomization

Secondary Outcomes (1)

• Pulmonary Embolism

  from the time of randomization to 90 days

Other Outcomes (1)

• 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.

Study Arms (2)

Intermittent Pneumatic Compression(IPC)

EXPERIMENTAL

The intervention group will be receiving Intermittent Pneumatic Compression(IPC)

Device: pneumatic compression

No Intermittent Pneumatic Compression

NO INTERVENTION

patients will not receive Intermittent Pneumatic Compression

Interventions

pneumatic compression DEVICE

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.

Intermittent Pneumatic Compression(IPC)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• King Abdulaziz Medical City, Jeddah: collaborator
• King Abdulaziz Hospital, Al Ahsa: collaborator
• Unity Health Toronto: collaborator
• King Fahad Medical City: collaborator
• Assir Central Hospital: collaborator
• Royal North Shore Hospital: collaborator
• Mount Sinai Hospital, Canada: collaborator
• Prince Sultan Military Medical City: collaborator
• King Faisal Specialist Hospital & Research Center: collaborator
• Gosford Hospital, Australia: collaborator
• St Vincent's Hospital - Sydney, Australia: collaborator
• Medanta, The Medicity, India: collaborator
• King Fahad Hospital of the University, Al Khobar: collaborator
• King George's Medical University, India: collaborator

Study Sites (1)

Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

Related Publications (7)

• 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. Performance of Risk Assessment Models for VTE in Patients Who Are Critically Ill Receiving Pharmacologic Thromboprophylaxis: A Post Hoc Analysis of the Pneumatic Compression for Preventing VTE Trial. Chest. 2025 Feb;167(2):598-610. doi: 10.1016/j.chest.2024.07.182. Epub 2024 Sep 2.

  PMID: 39232999 DERIVED

• Al-Dorzi HM, AlQahtani S, Al-Dawood A, 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, Arabi YM; Saudi Critical Care Trials Group. Association of early mobility with the incidence of deep-vein thrombosis and mortality among critically ill patients: a post hoc analysis of PREVENT trial. Crit Care. 2023 Mar 3;27(1):83. doi: 10.1186/s13054-023-04333-9.

  PMID: 36869382 DERIVED

• 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. The effect of intermittent pneumatic compression on deep-vein thrombosis and ventilation-free days in critically ill patients with heart failure. Sci Rep. 2022 May 20;12(1):8519. doi: 10.1038/s41598-022-12336-9.

  PMID: 35595804 DERIVED

• 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. Surveillance or no surveillance ultrasonography for deep vein thrombosis and outcomes of critically ill patients: a pre-planned sub-study of the PREVENT trial. Intensive Care Med. 2020 Apr;46(4):737-746. doi: 10.1007/s00134-019-05899-1. Epub 2020 Feb 24.

  PMID: 32095845 DERIVED

• Arabi YM, Al-Hameed F, Burns KEA, Mehta S, Alsolamy SJ, 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, Abdukahil SAI, Jose J, Afesh LY, Al-Dawood A; Saudi Critical Care Trials Group. Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis. N Engl J Med. 2019 Apr 4;380(14):1305-1315. doi: 10.1056/NEJMoa1816150. Epub 2019 Feb 18.

  PMID: 30779530 DERIVED

• 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. Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial. Trials. 2018 Mar 15;19(1):182. doi: 10.1186/s13063-018-2534-6.

  PMID: 29544550 DERIVED

• 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. Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial. Trials. 2016 Aug 3;17(1):390. doi: 10.1186/s13063-016-1520-0.

  PMID: 27488380 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Yaseen Arabi, MD

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Intensive Care Department

Study Record Dates

• First Submitted: November 3, 2013
• First Posted: January 20, 2014
• Study Start: July 16, 2014
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

SA (1)