Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage

March 22, 2026 updated by: Pryamikov Aleksandr, Pirogov Russian National Research Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander Pryamikov, MD, PhD, Associate Professor
  • Phone Number: +7 (903) 286-25-52
  • Email: pryamikov80@rambler.ru

Study Locations

  • Russia
      • Moscow, Russia, 115516
        • Recruiting
        • Moscow City Clinical Hospital named after V.M. Buyanov
        • Contact:
          • Alexander Pryamikov, MD, PhD, Associate Professor
          • Phone Number: +7 (903) 286-25-52
          • Email: pryamikov80@rambler.ru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Prophylactic dosage and administration of unfractionated heparin or low molecular weight heparin according to their official prescribing information.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with acute venous thrombosis established using ultrasound examination
Time Frame: 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.
Acute venous thrombosis in the study is defined as the development of a blood clot in lower extremity veins and/or pelvic veins and/or inferior vena cava (IVC) and/or IVC tributaries.
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.
Number of participants with pulmonary embolism established using CT pulmonary angiogram
Time Frame: 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.
Pulmonary embolism in the study is defined as the development of acute fatal or nonfatal pulmonary embolism.
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.
Number of participants with intracerebral hemorrhage expansion detected using brain CT scan
Time Frame: 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.
Intracerebral hemorrhage expansion in the study is defined as hematoma volume absolute increase of > 6 ml and/or relative increase of > 33% compared to its baseline volume.
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.
Number of participants with intracranial bleeding complications requiring urgent neurosurgical management
Time Frame: 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.
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.
Number of participants with clinically significant bleeding beyond the braincase requiring the discontinuation of heparin administration
Time Frame: 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.
Bleeding beyond the braincase (e.g., nosebleed, gastrointestinal bleeding, hemoptysis, etc.) is defined as clinically significant if it: 1) requires transfusion of red blood cells, 2) prolongs a hospitalization, with bleeding as the principal reason, 3) requires surgery to stop the bleeding, or 4) results in death.
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.
Inpatient death rate (mortality)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24421102024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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