NCT04710732: IDAHeT

Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test.

Terminated Phase 4 Last updated 7 January 2025

What this trial tests

Phase 4 trial testing Standard Enoxaparin 40 mg once-daily before randomization in Venous Thromboembolism in 9 participants. Terminated before completion.

Timeline

1 March 2021

Primary endpoint
31 December 2023

31 January 2024

Quick facts

Lead sponsor	Pirogov Russian National Research Medical University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	9
Start date	1 March 2021
Primary completion	31 December 2023
Estimated completion	31 January 2024
Sites	1 location across Russia

Drugs / interventions tested

• Standard Enoxaparin 40 mg once-daily before randomization — full drug profile →
• Standard Enoxaparin 40 mg once-daily after randomization — full drug profile →
• Escalated Enoxaparin 30 mg twice-daily after randomization — full drug profile →
• Anti-embolic elastic compression stockings
• Thrombodynamic test (TD)

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →

Sponsor

Pirogov Russian National Research Medical University

Who can join

18 and older, any sex, with Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.