Status:
TERMINATED
Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test.
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the efficacy and safety of individual dose adjustment of low molecular weight heparin (LMWH) based on the results of the thrombodynamics test (TD) in patients at e...
Eligibility Criteria
Inclusion
- performed major surgery;
- performed the key injection 1 and the key injection 2 of enoxaparin 40 mg;
- performed thrombodynamics test at 12 hours after the key injection 1 and at 24 hours after the key injection 2;
- at least one of the relevant TD parameters exceeds the set threshold: initial velocity of clot growth \>62.5 μm / min at 12 hours after the key injection 1, or initial velocity of clot growth \>64.5 μm / min at 24 hours after the key injection 2, or clot size \>1333.5 μm at 12 hours after the key injection 1, or clot size \>1351.5 μm at 24 hours after the key injection 2;
- Caprini score of 13 and higher after recalculation with the results of the TD test;
- infirmed consent is given.
Exclusion
- 60 or more hours passed since the end of surgery;
- venous thrombosis at the baseline;
- performed partial occlusion of the inferior vena cava (plication, filter);
- indications for the use of anticoagulants in different regimen;
- high risk of bleeding;
- contraindication to anticoagulation;
- contraindication to elastic compression;
- inability for blood sampling from a peripheral vein;
- anticipated death within 5 days or less.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04710732
Start Date
March 1 2021
End Date
January 31 2024
Last Update
January 7 2025
Active Locations (1)
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1
Moscow Clinical Hospital no.24
Moscow, Russia, 127015