Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage

Primary outcomes

1. Number of participants with acute venous thrombosis established using ultrasound examination

   Time frame: From the beginning of venous thromboembolism prophylaxis using heparin until the date of acute venous thrombosis detection or the date of death from any cause, whichever came first, assessed up to hospital discharge but not longer than 6 months.

   Acute venous thrombosis in the study is defined as the development of a blood clot in lower extremity veins and/or pelvic veins and/or inferior vena cava (IVC) and/or IVC tributaries.

2. Number of participants with pulmonary embolism established using CT pulmonary angiogram

   Time frame: From the beginning of venous thromboembolism prophylaxis using heparin until the date of pulmonary embolism detection or the date of death from any cause, whichever came first, assessed up to hospital discharge but not longer than 6 months.

   Pulmonary embolism in the study is defined as the development of acute fatal or nonfatal pulmonary embolism.

3. Number of participants with intracerebral hemorrhage expansion detected using brain CT scan

   Time frame: From the beginning of venous thromboembolism prophylaxis using heparin until the date of first documented hemorrhage expansion or the date of death from any cause, whichever came first, assessed up to hospital discharge but not longer than 6 months.

   Intracerebral hemorrhage expansion in the study is defined as hematoma volume absolute increase of > 6 ml and/or relative increase of > 33% compared to its baseline volume.

4. Number of participants with intracranial bleeding complications requiring urgent neurosurgical management

   Time frame: From the beginning of venous thromboembolism prophylaxis using heparin until the date when the event of interest happens or the date of death from any cause, whichever came first, assessed up to hospital discharge but not longer than 6 months.

5. Number of participants with clinically significant bleeding beyond the braincase requiring the discontinuation of heparin administration

   Time frame: From the beginning of venous thromboembolism prophylaxis using heparin until the date when the outcome of interest happens or the date of death from any cause, whichever came first, assessed up to hospital discharge but not longer than 6 months.

   Bleeding beyond the braincase (e.g., nosebleed, gastrointestinal bleeding, hemoptysis, etc.) is defined as clinically significant if it: 1) requires transfusion of red blood cells, 2) prolongs a hospitalization, with bleeding as the principal reason, 3) requires surgery to stop the bleeding, or 4) results in death.

6. Inpatient death rate (mortality)

   Time frame: Starting on the 3rd day after hospital admission until the date of inpatient death or the date of hospital discharge, whichever came first, assessed up to 6 months.