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

被引：9

作者：

Arabi, Yaseen ^{[1
]}

Al-Hameed, Fahad ^{[2
]}

Burns, Karen E. A. ^{[3
]}

Mehta, Sangeeta ^{[4
]}

Alsolamy, Sami ^{[1
]}

Almaani, Mohammed ^{[5
]}

Mandourah, Yasser ^{[6
]}

Almekhlafi, Ghaleb A. ^{[6
]}

Al Bshabshe, Ali ^{[7
]}

Finfer, Simon ^{[8
,9
]}

Alshahrani, Mohammed ^{[10
]}

Khalid, Imran ^{[11
]}

Mehta, Yatin ^{[12
]}

Gaur, Atul ^{[13
]}

Hawa, Hassan ^{[14
]}

Buscher, Hergen ^{[15
]}

Arshad, Zia ^{[16
]}

Lababidi, Hani ^{[17
]}

Al Aithan, Abdulsalam ^{[18
]}

Jose, Jesna ^{[1
]}

Abdukahil, Sheryl Ann I. ^{[1
]}

Afesh, Lara Y. ^{[1
]}

Dbsawy, Maamoun ^{[1
]}

Al-Dawood, Abdulaziz ^{[1
]}

机构：

[1] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

[2] Coll Med Jeddah, King Abdullah Int Med Res Ctr, King Saud Bin Abdulaziz Univ Hlth Sci, Dept Intens Care, Jeddah, Saudi Arabia

[3] St Michaels Hosp, Li Ka Shing Knowledge Inst, Interdept Div Crit Care Med, Toronto, ON, Canada

[4] Mt Sinai Hosp, Interdeptl Div Crit Care Med, Toronto, ON, Canada

[5] King Saud Bin Abdulaziz Univ Hlth Sci, Dept Pulm & Crit Care Med, King Fahad Med City, Riyadh, Saudi Arabia

[6] Prince Sultan Mil Med City, Dept Intens Care Serv, Riyadh, Saudi Arabia

[7] King Khalid Univ, Asir Cent Hosp, Dept Crit Care Med, Abha, Saudi Arabia

[8] Royal North Shore Hosp, Intens Care, Sydney, NSW, Australia

[9] Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia

[10] Imam Abdulrahman Bin Faisal Univ Al Khobar, Dept Emergency & Crit Care, Al Khobar, Saudi Arabia

[11] King Faisal Specialist Hosp & Res Ctr, Dept Med, Crit Care Sect, Jeddah, Saudi Arabia

[12] Inst Crit Care & Anaesthesiol Medanta Medic, Gurgaon, Haryana, India

[13] Gosford Hosp, Intens Care Dept, Gosford, NSW, Australia

[14] King Faisal Specialist Hosp & Res Ctr, Crit Care Med Dept, Riyadh, Saudi Arabia

[15] St Vincents Hosp, Intens Care Med, Sydney, NSW, Australia

[16] King Georges Med Univ, Dept Anesthesiol & Crit Care, Lucknow, Uttar Pradesh, India

[17] King Fahad Med City, Dept Pulm & Crit Care Med, Riyadh, Saudi Arabia

[18] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Intens Care & Pulm Med, Al Hasa, Saudi Arabia

来源：

TRIALS | 2018年 / 19卷

关键词：

Deep vein thrombosis; Pulmonary embolism; Intermittent pneumatic compression; Adjunct mechanical and pharmacologic DVT prophylaxis; Critically-ill patients; CHRONIC HEART-FAILURE; DEEP-VEIN THROMBOSIS; EJECTION FRACTION; VTE; HAD;

D O I：

10.1186/s13063-018-2534-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. Methods/design: In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Discussion: Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.

引用

页数：10

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