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Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT)

Primary Purpose

Deep Venous Thrombosis

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

pneumatic compression

About this trial

This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring Deep Vein Thrombosis, Pulmonary Embolism, Intermittent Pneumatic Compression, Pharmacologic DVT, Prophylaxis, Critically Ill Patients.

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intermittent Pneumatic Compression(IPC)

No Intermittent Pneumatic Compression

Arm Description

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

patients will not receive Intermittent Pneumatic Compression

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary Embolism

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.

Full Information

NCT ID

NCT02040103

First Posted

November 3, 2013

Last Updated

December 10, 2018

Sponsor

King Abdullah International Medical Research Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02040103

Brief Title

Pneumatic Compression for Preventing Venous Thromboembolism

Acronym

PREVENT

Official Title

Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

July 16, 2014 (Actual)

Primary Completion Date

November 13, 2018 (Actual)

Study Completion Date

November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Abdullah International Medical Research Center

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Venous Thrombosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent Pneumatic Compression(IPC)

Arm Type

Experimental

Arm Description

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

Arm Title

No Intermittent Pneumatic Compression

Arm Type

No Intervention

Arm Description

patients will not receive Intermittent Pneumatic Compression

Intervention Type

Device

Intervention Name(s)

pneumatic compression

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound

Description

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

Time Frame

28 days from randomization

Secondary Outcome Measure Information:

Title

Pulmonary Embolism

Description

Time Frame

from the time of randomization to 90 days

Other Pre-specified Outcome Measures:

Title

ICU Length of stay and duration of mechanical ventilation

Description

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.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaseen Arabi, MD

Organizational Affiliation

King Abdullah International Medical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Riyadh

ZIP/Postal Code

11426

Country

Saudi Arabia

12. IPD Sharing Statement

Citations:

PubMed Identifier

35595804

Citation

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.

Results Reference

derived

PubMed Identifier

32095845

Citation

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.

Results Reference

derived

PubMed Identifier

30779530

Citation

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.

Results Reference

derived

PubMed Identifier

29544550

Citation

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.

Results Reference

derived

PubMed Identifier

27488380

Citation

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. Erratum In: Trials. 2016;17(1):420.

Results Reference

derived

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Pneumatic Compression for Preventing Venous Thromboembolism

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