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 |