Venous ThromboembolismPhase 4IDAHeTNCT04710732
Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test.
A Phase 4 study testing Standard Enoxaparin 40 mg once-daily before randomization, Standard Enoxaparin 40 mg once-daily after randomization and Escalated Enoxaparin 30 mg twice-daily after randomization in people with Venous Thromboembolism, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Standard Enoxaparin 40 mg once-daily before randomization, Standard Enoxaparin 40 mg once-daily after randomization and Escalated Enoxaparin 30 mg twice-daily after randomization
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2021to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- contraindication to elastic compression;
- inability for blood sampling from a peripheral vein;
- anticipated death within 5 days or less.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test in Patients At Extremely High Risk of Postoperative Venous Thromboembolism.
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.
Read more
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.
- Conditions
- Venous Thromboembolism
- Being tested
- Standard Enoxaparin 40 mg once-daily before randomization, Standard Enoxaparin 40 mg once-daily after randomization, Escalated Enoxaparin 30 mg twice-daily after randomization, Anti-embolic elastic compression stockings, Thrombodynamic test (TD)
- Keywords
- deep vein thrombosis, pulmonary embolism, venous thromboembolism, caprini score, prophylaxis, low molecular weight heparin
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Enoxaparin 40 mg once-daily before randomizationDrug
Once-daily subcutaneous injection of a standard prophylactic dose of Enoxaparin 40 mg according to the set schedule:
- 12 hours before the surgery (if applicable) on a postoperative day -1 (POD -1)
- 6-12 hours after the surgery (key injection 1) on the surgery day (POD 0)
- 12 hours after the previous key injection 1 (key injection 2) on the POD 1
- 24 hours after the previous key injection 2 on the POD 2
Standard Enoxaparin 40 mg once-daily after randomizationDrug
Once-daily subcutaneous injection (every 24 hours) of a standard prophylactic dose of Enoxaparin 40 mg since POD 3 and until discharge
Escalated Enoxaparin 30 mg twice-daily after randomizationDrug
Twice-daily subcutaneous injection (every 12 hours) of an escalated prophylactic dose of Enoxaparin 30 mg since POD 3 and until discharge
Anti-embolic elastic compression stockingsDevice
Applied before or just after the surgery and used around the clock until discharge
Thrombodynamic test (TD)Diagnostic test
Blood sampling for TD:
- 12 hours after key injection 1 (TD-12) on the POD 1
- 24 hours after key injection 2 (TD-24) on the POD 2
- 24 hours after each daily injection on the POD 4 (TD-4) and POD 5 (TD-5)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Peri-operative VTE prophylaxis with a standard once-daily dose of enoxaparin 40 mg and anti-embolic stockings Receives: Drug: Standard Enoxaparin 40 mg once-daily before randomization; Drug: Standard Enoxaparin 40 mg once-daily after randomization; Device: Anti-embolic elastic compression stockings; Diagnostic Test: Thrombodynamic test (TD) |
| Experimental | Experimental | Peri-operative VTE prophylaxis with an escalated twice-daily dose of enoxaparin 30 mg and anti-embolic stockings Receives: Drug: Standard Enoxaparin 40 mg once-daily before randomization; Drug: Escalated Enoxaparin 30 mg twice-daily after randomization; Device: Anti-embolic elastic compression stockings; Diagnostic Test: Thrombodynamic test (TD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic and asymptomatic venous thrombosis by postoperative day 10
The number of patients with a combination of asymptomatic DVT or SVT revealed by routine DUS performed by blinded assessor between 7 and 10 postoperative day and symptomatic DVT or SVT confirmed by unscheduled DUS.
Measured: day 10 after surgery
Secondary outcomes (12)
The number of patients with the reduction of any relevant parameter of the TD test by postoperative day 5
The number of patients in whom any relevant parameter of the TD test does not exceed the set threshold at control blood test on POD-5 (TD-5):
-initial velocity of clot growth (Vin) <62.5 μm / min at 12 hours after enoxaparin 30 mg injection (experimental group) or <64.5 μm / min at 24 hours after enoxaparin 40 mg injection (control group)
or
-clot size (CS): <1333.5 μm at 12 hours after enoxaparin 30 mg injection (experimental group) or <1351.5 μm / min at 24 hours after enoxaparin 40 mg injection (control group)
Measured: day 5 after surgery
The number of patients with the reduction of all relevant parameters of the TD test by postoperative day 5
The number of patients in whom all relevant parameters of the TD test do not exceed the set threshold at control blood test on POD-5 (TD-5):
-initial velocity of clot growth (Vin) <62.5 μm / min at 12 hours after enoxaparin 30 mg injection (experimental group) and <64.5 μm / min at 24 hours after enoxaparin 40 mg injection (control group)
and
-clot size (CS): <1333.5 μm at 12 hours after enoxaparin 30 mg injection (experimental group) and <1351.5 μm / min at 24 hours after enoxaparin 40 mg injection (control group)
Measured: day 5 after surgery
The number of patients with the normalization of every parameter of the TD test by postoperative day 5
The number of patients in whom every parameter of the TD test does not exceed the upper limit of normal at control blood test on POD-5 (TD-5):
- initial velocity of clot growth (Vin) <56 μm / min, and
- clot size (CS): <1200 μm, and
- lag-time: >0.6 sec, and
- stationary velocity of clot growth: <29 μm / min, and
- clot density: <32000 c.u., and
- spontaneous clots: negative.
Measured: day 5 after surgery
Symptomatic and asymptomatic venous thromboembolism by postoperative day 10
The number of patients with a combination of asymptomatic DVT or SVT revealed by routine DUS performed by blinded assessor between 7 and 10 postoperative day and symptomatic DVT, SVT, or PE confirmed by unscheduled DUS, CTPA, or autopsy.
Measured: day 10 after surgery
Symptomatic pulmonary embolism by postoperative day 10
The number of patients with symptomatic pulmonary embolism confirmed by CTPA or autopsy
Measured: day 10 after surgery
Fatal pulmonary embolism by postoperative day 10
The number of patients with fatal pulmonary embolism confirmed by autopsy
Measured: day 10 after surgery
Death by postoperative day 10
The number of patients who died for any reason within 10 days after surgery
Measured: day 10 after surgery
Symptomatic and asymptomatic venous thromboembolism by postoperative day 30
The number of patients with a combination of asymptomatic DVT or SVT revealed by routine DUS performed by blinded assessor between 7 and 10 postoperative day and symptomatic DVT, SVT, or PE confirmed by appropriate medical image or autopsy within 30 days after surgery as revealed by clinical examination, the examination of medical records or telephone interview.
Measured: day 30 after surgery
Death by postoperative day 30
The number of patients who died for any reason within 30 days after surgery as revealed by the telephone interview and/or examination of medical records.
Measured: day 30 after surgery
Major bleeding by postoperative day 30
The number of patients with major bleeding as defined by the International Society of Thrombosis and Hemostasis occurred within 30 days after surgery as assessed by the Data Monitoring Committee.
Measured: day 30 after surgery
Clinically relevant non-major bleeding by postoperative day 30
The number of patients with clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Hemostasis occurred within 30 days after surgery as assessed by the Data Monitoring Committee.
Measured: day 30 after surgery
Minor bleeding by postoperative day 30
The number of patients with any other bleeding not fulfilling the criteria of major nor clinically relevant non-major bleeding that occurred within 30 days after surgery as assessed by the Data Monitoring Committee.
Measured: day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Why it stopped: Lack of the eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Lobastov, Pirogov Russian National Research Medical University
- Investigators
- Kirill Lobastov, PhD, Principal investigator, Pirogov RNRMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710732
- Sponsor's protocol ID
- IDAHeT
- Acronym
- IDAHeT
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Dose Adjustment of Low-molecular-weight-heparin by Thromodynamics Test in Patients At Extremely High Risk of Postoperative Venous Thromboembolism.
- ClinicalTrials.gov ID
- NCT04710732
- Acronym / sponsor ID
- IDAHeT / IDAHeT
- Conditions
- Venous Thromboembolism
- Keywords
- deep vein thrombosis, pulmonary embolism, venous thromboembolism, caprini score, prophylaxis, low molecular weight heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of the eligible patients
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Standard Enoxaparin 40 mg once-daily before randomization, Drug: Standard Enoxaparin 40 mg once-daily after randomization, Device: Anti-embolic elastic compression stockings, Diagnostic Test: Thrombodynamic test (TD)Peri-operative VTE prophylaxis with a standard once-daily dose of enoxaparin 40 mg and anti-embolic stockings |
| Experimental | Experimental | Drug: Standard Enoxaparin 40 mg once-daily before randomization, Drug: Escalated Enoxaparin 30 mg twice-daily after randomization, Device: Anti-embolic elastic compression stockings, Diagnostic Test: Thrombodynamic test (TD)Peri-operative VTE prophylaxis with an escalated twice-daily dose of enoxaparin 30 mg and anti-embolic stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Enoxaparin 40 mg once-daily before randomizationOnce-daily subcutaneous injection of a standard prophylactic dose of Enoxaparin 40 mg according to the set schedule: * 12 hours before the surgery (if applicable) on a postoperative day -1 (POD -1) * 6-12 hours after the surgery (key injection 1) on the surgery day (POD 0) * 12 hours after the previous key injection 1 (key injection 2) on the POD 1 * 24 hours after the previous key injection 2 on the POD 2 | Drug | Control, Experimental |
| Standard Enoxaparin 40 mg once-daily after randomizationOnce-daily subcutaneous injection (every 24 hours) of a standard prophylactic dose of Enoxaparin 40 mg since POD 3 and until discharge | Drug | Control |
| Escalated Enoxaparin 30 mg twice-daily after randomizationTwice-daily subcutaneous injection (every 12 hours) of an escalated prophylactic dose of Enoxaparin 30 mg since POD 3 and until discharge | Drug | Experimental |
| Anti-embolic elastic compression stockingsApplied before or just after the surgery and used around the clock until discharge | Device | Control, Experimental |
| Thrombodynamic test (TD)Blood sampling for TD: * 12 hours after key injection 1 (TD-12) on the POD 1 * 24 hours after key injection 2 (TD-24) on the POD 2 * 24 hours after each daily injection on the POD 4 (TD-4) and POD 5 (TD-5) | Diagnostic test | Control, Experimental |
Primary outcome
Symptomatic and asymptomatic venous thrombosis by postoperative day 10
Time frame: day 10 after surgery
The number of patients with a combination of asymptomatic DVT or SVT revealed by routine DUS performed by blinded assessor between 7 and 10 postoperative day and symptomatic DVT or SVT confirmed by unscheduled DUS.
12 secondary outcomes
The number of patients with the reduction of any relevant parameter of the TD test by postoperative day 5
Time frame: day 5 after surgery
The number of patients with the reduction of all relevant parameters of the TD test by postoperative day 5
Time frame: day 5 after surgery
The number of patients with the normalization of every parameter of the TD test by postoperative day 5
Time frame: day 5 after surgery
Symptomatic and asymptomatic venous thromboembolism by postoperative day 10
Time frame: day 10 after surgery
Symptomatic pulmonary embolism by postoperative day 10
Time frame: day 10 after surgery
Fatal pulmonary embolism by postoperative day 10
Time frame: day 10 after surgery
Death by postoperative day 10
Time frame: day 10 after surgery
Symptomatic and asymptomatic venous thromboembolism by postoperative day 30
Time frame: day 30 after surgery
Death by postoperative day 30
Time frame: day 30 after surgery
Major bleeding by postoperative day 30
Time frame: day 30 after surgery
Clinically relevant non-major bleeding by postoperative day 30
Time frame: day 30 after surgery
Minor bleeding by postoperative day 30
Time frame: day 30 after surgery
Results and safety
The study was stopped early (reason given: Lack of the eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirill Lobastov, PhD principal investigator
Pirogov RNRMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Enoxaparin 40 mg once-daily before randomization, Standard Enoxaparin 40 mg once-daily after randomization and Escalated Enoxaparin 30 mg twice-daily after randomization in people with Venous Thromboembolism, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of the eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic and asymptomatic venous thrombosis by postoperative day 10 (time frame: day 10 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.