Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT04710732
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04710732
Study Brief:
Protocol Section:
NCT04710732