Timing of Venous Thromboembolism Prophylaxis in Patients with Hypertensive Intracerebral Hemorrhage

Pirogov Russian National Research Medical University

Status: Enrolling

Conditions: Pulmonary Embolism; Venous Thromboembolism; Deep Vein Thrombosis; Intracerebral Hemorrhage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06753786

24421102024

Details and patient eligibility

About

The objective of this randomized clinical trial is to evaluate the safety and efficiency of different anticoagulation schemes with heparin for venous thromboembolism prevention in patients with hypertensive intracerebral hemorrhage. The main questions it aims to answer are:

• What is the optimal time for the beginning of anticoagulation with heparin to efficiently prevent venous thromboembolism in patients with hypertensive intracerebral hemorrhage? Early beginning (within the first 2 days but not earlier than 12 hours after the admission of a patient) or delayed beginning (on the third day after the admission of a patient)?
• Which of the two timeframes (early or delayed) for anticoagulation beginning is the most safe in terms of bleeding complications including intracerebral hemorrhage expansion?

Researchers will compare the results of early and delayed start of anticoagulation using heparin in patients with hypertensive intracerebral hemorrhage to define the optimal start time for anticoagulation that provides the most favourable efficiency/safety profile.

Participants will:

• Undergo a computed tomography (CT) scan of the brain on hospital admission and then 12-24 hours after the hospital admission and 24 hours after the beginning of venous thromboembolism prophylaxis using heparin;
• Undergo the ultrasound examination of lower extremity deep veins on hospital admission and then once every 7 days;
• Receive prophylactic doses of low molecular weight heparin or unfractionated heparin either beginning within the first 2 days but not earlier than 12 hours after the hospital admission or starting on the 3rd day after the hospital admission.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the presence of hypertensive intracerebral hemorrhage

Exclusion criteria

• Intracerebral hemorrhage expansion detected on the basis of a computed tomography scan of the brain 12-24 hours after a hospital admission (i.e. before the initiation of venous thromboembolism prophylaxis with heparin)
• Being on an anticoagulant during preadmission period and on day of hospital admission
• Death within the first 2 days after hospital admission
• Detection of venous thromboembolism in a patient at the moment of hospital admission
• Surgical management of hypertensive intracerebral hemorrhage before the beginning of venous thromboembolism prophylaxis using heparin
• The presence of a malignancy (cancer) in a patient at the moment of hospital admission

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early beginning of venous thromboembolism prophylaxis in patients with intracerebral hemorrhage

Experimental group

Description:

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.

Treatment:

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.

Delayed beginning of venous thromboembolism prophylaxis in patients with intracerebral hemorrhage

Experimental group

Description:

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.

Treatment:

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