Timing of Venous Thromboembolism Prophylaxis in Patients with Hypertensive Intracerebral Hemorrhage

NCT ID: NCT06753786

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2028-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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.

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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.

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

Intervention Type: DRUG

Venous 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Pryamikov Aleksandr

MD, PhD (DMedSc [Russia]), Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Moscow City Clinical Hospital named after V.M. Buyanov

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexander Pryamikov, MD, PhD, Associate Professor

Role: CONTACT

Phone: +7 (903) 286-25-52

Email: pryamikov80@rambler.ru

Facility Contacts

Alexander Pryamikov, MD, PhD, Associate Professor

Role: primary

Other Identifiers

24421102024

Identifier Type: -

Identifier Source: org_study_id