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Randomized Controlled Trial
. 2018 Sep;97(36):e12258.
doi: 10.1097/MD.0000000000012258.

Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan

Yaseen M Arabi  1 , Karen E A Burns, Fahad Al-Hameed, Sami Alsolamy, Mohammed Almaani, Yasser Mandourah, Ghaleb A Almekhlafi, Ali Al Bshabshe, Mohammed Alshahrani, Imran Khalid, Hassan Hawa, Zia Arshad, Hani Lababidi, Abdulsalam Al Aithan, Jesna Jose, Sheryl Ann I Abdukahil, Lara Y Afesh, Abdulaziz Al-Dawood; and the PREVENT trial Group
Affiliations
Randomized Controlled Trial

Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients: A study protocol and statistical analysis plan

Yaseen M Arabi et al. Medicine (Baltimore). 2018 Sep.

Abstract

Objective: Surveillance ultrasounds in critically ill patients detect many deep venous thrombi (DVTs) that would otherwise go unnoticed. However, the impact of surveillance for DVT on mortality among critically ill patients remains unclear.

Design: We are conducting a multicenter, multinational randomized controlled trial that examines the effectiveness of adjunct intermittent pneumatic compression use with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on the incidence of proximal lower extremity DVT in critically ill patients (the PREVENT trial). Enrolled patients undergo twice weekly surveillance ultrasounds of the lower extremities as part of the study procedures. We plan to compare enrolled patients who have surveillance ultrasounds to patients who meet the eligibility criteria but are not enrolled (eligible non-enrolled patients) and only who will have ultrasounds performed at the clinical team's discretion. We hypothesize that twice-weekly ultrasound surveillance for DVT in critically ill patients who are receiving thromboprophylaxis will have more DVTs detected, and consequently, fewer pulmonary emboli and lower all-cause 90-day mortality.

Discussion: We developed a detailed a priori plan to guide the analysis of the proposed study and enhance the validity of its results.

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Conflict of interest statement

The authors report no conflicts interest.

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