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Table 2 Intervention stopping rules

From: Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Event

Action regarding the intervention

Action regarding other study procedures (data collection, ultrasounds, 28- and 90-day outcomes)

Suspected DVT

Hold intervention temporarily

Continue other study procedures

Confirmed DVT

Stop intervention permanently

This is a predefined endpoint

Suspected PE

Hold intervention temporarily

Continue other study procedures

Confirmed PE

Stop intervention permanently

This is a predefined endpoint

Non-lower extremity thrombosis

Continue intervention

Continue other study procedures

Anticoagulation for reasons other than PE or DVT

Continue intervention

Continue other study procedures

Prophylactic IVC filter placement

Continue intervention

Continue other study procedures

Severe skin ulcerations due to IPC

Hold intervention temporarily

Continue other study procedures

Ischemia due to IPC

Hold intervention temporarily

Continue other study procedures

Intolerance of IPC

Hold intervention temporarily

Continue other study procedures

Withdrawal from the study

Stop intervention permanently

Ask for permission to continue, if not stop.

Pharmacologic thromboprophylaxis is withheld

Apply IPC until pharmacologic prophylaxis is resumed (in both groups)

Continue other study procedures

Physician requests IPC in the control group

Place IPC and document the reason

Continue other study procedures

IPC not placed by mistake in the IPC group or placed by mistake in the control group

Resume the assigned intervention as soon as possible, document the reason, report as a violation

Continue other study procedures

Change in focus of care to palliation

Stop intervention permanently. IPC may be used at the discretion of the treating team

Stop ultrasounds. Continue other study procedures

  1. DVT deep vein thrombosis, IPC intermittent pneumatic compression, IVC inferior vena cava, PE pulmonary embolus