Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test.
Status:
Recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
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 extremely high risk of postoperative venous thromboembolism (VTE).
This is a single-center, open-label, randomized clinical study with a blinded assessor for
primary efficacy outcome.
Patients after elective or emergent major surgery having 10 or more Caprini scores at the
baseline, who already received two subcutaneous injections of enoxaparin: 40 mg at 6-12 hours
after the surgery ("key injection 1") and 40 mg at 12 hours after the previous injection
("key injection 2"), who had no VTE at the baseline, and who signed informed consent, are
subjected to laboratory examination by the TD.
Blood samples are taken 12 hours after the "key injection 1" and 24 hours after the "key
injection 2". If one of the relevant parameters of the TD (initial velocity of clot growth
rate and clot size) exceeds the set threshold, the Caprini scores are recalculated adding 3
points for "other thrombophilic state" confirmed by the thrombodynamics. The patient may be
included in the study if the new sum exceeds 13 points (initial 10 scores + additional 3
scores). Within 60 hours from the surgery, the included patients are randomly allocated to
one of two groups: Experimental or Control. Patients in the Control group continue to receive
the standard dose of enoxaparin 40 mg every 24 hours (once daily). In the Experimental group,
the dose of enoxaparin is increased to 30 mg every 12 hours (twice daily).
Blood samples for TD are taken during the next two days at 24 hours after the administration
of each daily dose of enoxaparin.
A whole leg duplex ultrasound scan (DUS) is performed in all patients during the screening
period and at 7-10 days after the surgery or in case of any suspicion for deep vein
thrombosis (DVT) or superficial vein thrombosis (SVT). Computed tomography pulmonary
angiography (CTPA) is carried out in any clinical suspicion for pulmonary embolism (PE). An
autopsy is performed in all dead patients.
The total follow-up period is 30 days. After discharge, patients are invited to the hospital
for clinical examination with DUS or interviewed by phone to identify symptomatic VTE.
Phase:
Phase 4
Details
Lead Sponsor:
Pirogov Russian National Research Medical University