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Pneumatic Compression for Preventing Venous Thromboembolism

NCT ID: NCT02040103

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-16

Study Completion Date

2018-11-13

Brief Summary

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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

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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.

Conditions

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Deep Venous Thrombosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intermittent Pneumatic Compression(IPC)

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

Group Type EXPERIMENTAL

pneumatic compression

Intervention Type 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.

No Intermittent Pneumatic Compression

patients will not receive Intermittent Pneumatic Compression

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pneumatic 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz Medical City, Jeddah

UNKNOWN

Sponsor Role collaborator

King Abdulaziz Hospital, Al Ahsa

UNKNOWN

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

King Fahad Medical City

OTHER_GOV

Sponsor Role collaborator

Assir Central Hospital

UNKNOWN

Sponsor Role collaborator

Royal North Shore Hospital

OTHER

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

Prince Sultan Military Medical City

OTHER

Sponsor Role collaborator

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role collaborator

Gosford Hospital, Australia

UNKNOWN

Sponsor Role collaborator

St Vincent's Hospital - Sydney, Australia

OTHER

Sponsor Role collaborator

Medanta, The Medicity, India

OTHER

Sponsor Role collaborator

King Fahad Hospital of the University, Al Khobar

UNKNOWN

Sponsor Role collaborator

King George's Medical University, India

UNKNOWN

Sponsor Role collaborator

King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr Yaseen Arabi

Chairman, Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaseen Arabi, MD

Role: PRINCIPAL_INVESTIGATOR

King Abdullah International Medical Research Center

Locations

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

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 39232999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36869382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35595804 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32095845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30779530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29544550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27488380 (View on PubMed)

Other Identifiers

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RC12-045

Identifier Type: -

Identifier Source: org_study_id