Early or Delayed Initiation of Venous Thromboembolism Prophylaxis with Heparin in Patients with Hypertensive Intracerebral Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• the presence of hypertensive intracerebral hemorrhage

Locations
Other Locations
Russian Federation
Moscow City Clinical Hospital named after V.M. Buyanov
RECRUITING
Moscow
Contact Information
Primary
Alexander Pryamikov, MD, PhD, Associate Professor
pryamikov80@rambler.ru
+7 (903) 286-25-52
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 200
Treatments
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.
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.
Sponsors
Leads: Pirogov Russian National Research Medical University

This content was sourced from clinicaltrials.gov