Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage

Browse trials for

• Venous Thromboembolism 712
• Pulmonary Embolism 832
• Cerebral Hemorrhage 457
• Venous Thrombosis 785

Keywords

• Prophylaxis
• Deep vein thrombosis
• Pulmonary embolism
• Venous thromboembolism
• Intracerebral hemorrhage
• Anticoagulation
• Low molecular weight heparin
• Unfractionated heparin

Venous Thromboembolism

712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.

This study's planned enrollment of 200 is below the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.

Lead sponsor

Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.

Study arms

• Experimental
  Early beginning of venous thromboembolism prophylaxis in patients with intracerebral hemorrhage

  Participants will receive prophylactic doses of unfractionated heparin or low molecular weight heparin starting within the first 2 days but not earlier than 12 hours after the hospital admission. If a participant is diagnosed with venous thromboembolism after the initiation of venous thromboembolism prophylaxis with heparin, the participant might receive therapeutic doses of unfractionated heparin or low molecular weight heparin by the joint decision of neuroemergency specialist, neurologist, neurosurgeon and vascular surgeon.

  Drug: Venous thromboembolism prophylaxis with unfractionated heparin or low molecular weight heparin starting within the first 2 days but not earlier than 12 hours after a hospital admission.

• Experimental
  Delayed beginning of venous thromboembolism prophylaxis in patients with intracerebral hemorrhage

  Participants will receive prophylactic doses of unfractionated heparin or low molecular weight heparin starting on the 3rd day after the hospital admission. If a participant is diagnosed with venous thromboembolism after the initiation of venous thromboembolism prophylaxis with heparin, the participant might receive therapeutic doses of unfractionated heparin or low molecular weight heparin by the joint decision of neuroemergency specialist, neurologist, neurosurgeon and vascular surgeon.

  Drug: Venous thromboembolism prophylaxis with unfractionated heparin or low molecular weight heparin starting on the 3rd day after a hospital admission.

Interventions

• DrugVenous thromboembolism prophylaxis with unfractionated heparin or low molecular weight heparin starting within the first 2 days but not earlier than 12 hours after a hospital admission.

  Prophylactic dosage and administration of unfractionated heparin or low molecular weight heparin according to their official prescribing information.

• DrugVenous thromboembolism prophylaxis with unfractionated heparin or low molecular weight heparin starting on the 3rd day after a hospital admission.

  Prophylactic dosage and administration of unfractionated heparin or low molecular weight heparin according to their official prescribing information.

Primary outcomes

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

   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.

   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.

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

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

   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.

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

   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.

   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.

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

   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.

   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.

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.

Individual participant data

Plan to share: No