The PREVENT trial: pneumatic compression for preventing venous thromboembolism

Not Applicable

Completed

• Conditions: Intensive care unit, critically ill patients, VTE prophylaxis; Circulatory System; Phlebitis and thrombophlebitis of other deep vessels of lower extremities

• Registration Number: ISRCTN44653506
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27488380 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30779530 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32095845 sub-study results (added 26/02/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35595804/ Secondary analysis (added 23/05/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36869382/ Post hoc analysis (added 06/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-30
• Study Completion: 2018-12-31
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2003

Inclusion Criteria

All patients (male + female) admitted to ICU will be screened for eligibility
1. Medical-Surgical ICU patients >14 years old
2. Weight > 45 kg
3. Expected ICU LOS> 72 hours
4. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH

Exclusion Criteria

Exclusion criteria as of 04/04/2017:
1. Patient treated with IPC for > 24 hours in this current ICU admission.
2. Patient in the ICU> 48 hours.
3. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.
4. Inability or contraindication to applying IPC to both legs or to obtain adequate ultrasound on the lower extremities
4.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings at the site of IPC placement or in the thighs that prevent adequate ultrasounds
4.2. Acute ischemia in the lower extremities
4.3. Amputated foot or leg on one or two sides
4.4. Compartment Syndrome
4.5. Severe peripheral arterial disease
4.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
4.7. Evidence of bone fracture in lower extremities
4.8. Arterial lines in the dorsalis pedis artery
5. Therapeutic dose of anticoagulation with UFH or LMWH
6. Pregnancy
7. Limitation of life support, life expectancy < 7 days or palliative care
8. Allergy to the sleeves material
9. Patients with Inferior Vena Cava (IVC) Filter

Eligible Non-Randomized Criteria
1. Patient or substitute decision maker declines consent but agrees to minimal data set collection
2. Unable to get consent within 48 hours of ICU admission
3. ICU physician or other treating clinician declines consent
4. Co-enrollment in trials with biologic interaction

Original exclusion criteria:
1. Patient on IPC for > 24 hours in this current ICU admission
2. Patient on pharmacologic prophylaxis with medications other than UFH or LMWH
3. Inability or contraindication to applying IPC to both legs:
3.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement
3.2. Acute ischemia in the lower extremities
3.3. Amputated foot or leg on one or two sides
3.4. Compartment Syndrome
3.5. Severe peripheral arterial disease
3.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
3.7. Evidence of bone fracture in lower extremities
4. The need for therapeutic anticoagulation
5. Pregnancy
6. Limitation of life support, life expectancy < 7 days or palliative care
7. Allergy to the sleeves material

Study & Design

• Study Type: Interventional
• Study Design: Not specified