NCT06753786 Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage
| NCT ID | NCT06753786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pirogov Russian National Research Medical University |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-21 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06753786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06753786 currently recruiting?
Yes, NCT06753786 is actively recruiting participants. Contact the research team at pryamikov80@rambler.ru for enrollment information.
Where is the NCT06753786 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06753786 clinical trial?
NCT06753786 is sponsored by Pirogov Russian National Research Medical University. The trial plans to enroll 200 participants.