Clinical trial NCT06753786: Timing of Venous Thromboembolism Prophylaxis in Patients with Hypertensive Intracerebral Hemorrhage
Official title: Early or Delayed Initiation of Venous Thromboembolism Prophylaxis with Heparin in Patients with Hypertensive Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Pulmonary Embolism
Intracerebral Hemorrhage
Deep Vein Thrombosis
Keywords: Prophylaxis
Deep vein thrombosis
Pulmonary embolism
Venous thromboembolism
Intracerebral hemorrhage
Anticoagulation
Low molecular weight heparin
Unfractionated heparin
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with acute venous thrombosis established using ultrasound examination
timeFrame: 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.
measure: Number of participants with pulmonary embolism established using CT pulmonary angiogram
timeFrame: 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.
measure: Number of participants with intracerebral hemorrhage expansion detected using brain CT scan
timeFrame: 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.
measure: Number of participants with intracranial bleeding complications requiring urgent neurosurgical management
timeFrame: 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.
measure: Number of participants with clinically significant bleeding beyond the braincase requiring the discontinuation of heparin administration
timeFrame: 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.
measure: Inpatient death rate (mortality)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital named after V.M. Buyanov
Study officials:
References: