Venous ThromboembolismVTEPXNCT01050153
The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma
A study testing Dalteparin sodium and Dalteparin sodium/aspirin in people with Venous Thromboembolism, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest. 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?
- Dalteparin sodium and Dalteparin sodium/aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age at least 18 years,
- blunt or penetrating trauma requiring admission to the SICU
- requirement for LMWH (Fragmin) therapy for prophylaxis of VTE as standard of care, and
- informed consent by patient, legally authorized representative or proxy decision maker (if patient incompetent to provide) obtained and documented.
Who cannot join
- Presence of any of the following absolute contraindications to LMWH (Fragmin) therapy:
- known hypersensitivity to dalteparin sodium,
- known hypersensitivity to heparin or pork products,
- thrombocytopenia associated with positive tests for antiplatelet antibody in the presence of Fragmin,
- history of heparin-induced thrombocytopenia (HIT),
- chronic liver disease (bilirubin >2 mg/dl) or kidney insufficiency (CrCl <30mL/min),
Show all 25Show fewer
- intravascular thrombolytic therapy within 24 hours,
- resuscitation that required massive transfusion (>10 units RBC within 6 hours),
- ongoing resuscitation for hemorrhagic shock,
- known bleeding disorder or coagulopathy (INR >2 not on warfarin),
- thrombocytopenia (platelets <20K/uL),
- subdural or epidural hematoma.
- Or
- Presence of any of the following relative contraindications to LMWH (Fragmin) therapy:
- new intracranial lesions, neoplasms or monitoring devices,
- extravascular thrombolytic therapy,
- severe uncontrolled hypertension,
- arterial dissection
- recent (within 12 hours) intraocular surgery (prior or planned),
- recent (within 72 hours) intracranial or spine surgery (prior or planned),
- conditions associated with increased risk of hemorrhage, e.g. active gastrointestinal ulceration, angiodysplastic disease, gastrointestinal bleeding within the past six months, bacterial endocarditis, history of hemorrhagic stroke, diabetic retinopathy.
- Or
- Presence, or removal within the last 12 hours, of an indwelling epidural or spinal catheter, OR recent (within the last 12 hours) or planned neuraxial (spinal/epidural) anesthesia or spinal puncture.
- Or
- Per history taken from patient or family, concomitant or known use within one week prior to hospitalization, of drugs affecting hemostasis such as NSAIDS, platelet inhibitors or other anticoagulants, except as specified in this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80203
About this study
Official title: An Evaluation of the Clinical Utility of Thrombelastography (TEG) in Guiding Low Molecular Weight Heparin (LMWH) and Antiplatelet Prophylaxis of Venous Thromboembolism (VTE) Following Trauma
This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest.
Usually, patients in the SICU at Denver Health who are at risk for blood clots receive preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to prevent blood clots from forming but, with the way it is generally used, some patients may still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver Health, currently receive the same Fragmin dose. This treatment is called the "standard of care".
Read more
So far, in the US, there has not been a commonly available test that can tell us:
- if the standard dose of Fragmin is enough to prevent blood clots for everyone, or
- if different patients need different doses, or
- if other blood clot preventing medicines, that work in a different way, should be used in addition to Fragmin.
The ability of your blood to clot and the strength of the clot formed can be described by a FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us with answers to each of the questions above. Our preliminary data indicate that it is helpful in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment for the prevention of blood clots.
The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated, one or two additional FDA-approved medicines called anti-platelet drugs, guided by the results of TEG testing, may be better at preventing blood clots than our current standard of care.
Read the detailed description
This preliminary/pilot study involves a prospective, randomized, open-label, parallel group comparison of Denver Health's current standard of care for prevention of venous thromboembolism (VTE), commonly known as blood clots, using LMWH (Fragmin) 5000IU subcutaneously daily, with a thrombelastography (TEG)-guided, algorithm-based, individualized regimen of LMWH (Fragmin) plus/minus anti-platelet therapy (aspirin) guided by platelet mapping, in patients admitted to the SICU following trauma.
Approximately 50 trauma patients for whom prevention of VTE with LMWH is indicated, will be enrolled over a six month period.
The specific aims of this study are as follows:
- To determine the incidence of, and to characterize, hypercoagulability using TEG and conventional clinical coagulation testing (APTT, INR), Antithrombin III levels and Protein C activity.
- In the group of patients receiving LMWH (Fragmin) therapy alone for prevention of VTE:
- to assess the anticoagulant effect of standard LMWH (Fragmin) dosing (5000IU subcutaneously once daily) using TEG and Anti-Factor Xa level measurement, and
- to determine the extent of correlation of relevant TEG parameters with measured Anti-Factor Xa levels (U/ml).
- To assess whether TEG is a useful clinical tool for monitoring and optimizing prophylactic LMWH (Fragmin) therapy and for identifying the need for anti-platelet therapy to minimize the risk of VTE in these patients.
- To evaluate the clinical utility of platelet mapping for guiding anti-platelet therapy in those patients for whom it is indicated by TEG results.
- To determine the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in each randomized group and in the subgroup receiving anti-platelet therapy in addition to LMWH (Fragmin) for prevention of VTE.
The overall aim is to utilize the above data to evaluate a) the adequacy of our standard Fragmin dosing regimen (5000IU subcutaneously once daily) alone for prevention of VTE in our trauma/SICU patients, b) the need for anti-platelet agents in addition to LMWH (Fragmin) for prevention of VTE in our population, and c) to validate/further develop the TEG-guided algorithm for optimal prophylaxis of VTE using LMWH (Fragmin) plus/minus anti-platelet therapy guided by platelet mapping.
- Conditions
- Venous Thromboembolism
- Being tested
- Dalteparin sodium, Dalteparin sodium/aspirin
- Keywords
- Prevention of venous thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin sodiumDrug
Also called Dalteparin sodium (Fragmin)
Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory
Dalteparin sodium/aspirinDrug
Also called dalteparin sodium (Fragmin)
Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po.
| Study group | Role | What they receive |
|---|---|---|
| Control (standard of care) | Active comparator | Dalteparin sodium 5000IU subcutaneously daily Receives: Drug: Dalteparin sodium |
| TEG-guided thromboprophylaxis | Experimental | Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm Receives: Drug: Dalteparin sodium/aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypercoagulability
To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.
Measured: Study day five.
Incidence of VTE
The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)
Measured: Day 28 or discharge, whichever comes first.
Secondary outcomes (8)
TEG Parameters
R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).
Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.
Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).
Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.
MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets.
Measured: Study day five.
International Normalized Ratio (INR)
Plasma based conventional coagulation testing parameters
Measured: Study day five.
Platelet Count
Platelet count measured by CBC test
Measured: Study day five.
TEG Parameters
Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).
The absolute SEMS of the sample can be calculated from MA as follows:
G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA.
Measured: Study day five.
Conventional Coagulation Testing Parameters
Plasma based conventional coagulation testing parameters - Anti Xa
Measured: Study day five.
Conventional Coagulation Testing Parameters
Plasma based conventional coagulation testing parameters - Fibrinogen
Measured: Study day five.
Conventional Coagulation Testing Parameters
Plasma based conventional coagulation testing parameters - Anti-thrombin III
Measured: Study day five.
Conventional Coagulation Testing Parameters
Plasma based conventional coagulation testing parameters - Protein C
Measured: Study day five.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Ernest E. Moore, MD, Denver Health and Hospital Authority
- Investigators
- Ernest E. Moore Jr, M.D., Principal investigator, Chief, Department of Surgery and Trauma Services , Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050153
- Sponsor's protocol ID
- COMIRB # 09-0753
- Acronym
- VTEPX
- Status last verified
- Dec 2018
- First submitted
- 13 Jan 2010
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Clinical Utility of Thrombelastography (TEG) in Guiding Low Molecular Weight Heparin (LMWH) and Antiplatelet Prophylaxis of Venous Thromboembolism (VTE) Following Trauma
- ClinicalTrials.gov ID
- NCT01050153
- Acronym / sponsor ID
- VTEPX / COMIRB # 09-0753
- Conditions
- Venous Thromboembolism
- Keywords
- Prevention of venous thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about how to prevent blood clots in the veins of your extremities. You are at risk of forming these clots after a major injury and when you have had surgery and are hospitalized on bed rest.
Usually, patients in the SICU at Denver Health who are at risk for blood clots receive preventative treatment with a FDA-approved medicine called Fragmin. Fragmin is intended to prevent blood clots from forming but, with the way it is generally used, some patients may still develop blood clots. All patients treated with Fragmin to prevent blood clots at Denver Health, currently receive the same Fragmin dose. This treatment is called the "standard of care".
So far, in the US, there has not been a commonly available test that can tell us:
- if the standard dose of Fragmin is enough to prevent blood clots for everyone, or
- if different patients need different doses, or
- if other blood clot preventing medicines, that work in a different way, should be used in addition to Fragmin.
The ability of your blood to clot and the strength of the clot formed can be described by a FDA-approved blood test called thrombelastography, referred to as TEG. TEG may provide us with answers to each of the questions above. Our preliminary data indicate that it is helpful in assessing both clotting and bleeding tendencies and may prove useful in guiding treatment for the prevention of blood clots.
The aim of this study is to determine if a treatment plan using Fragmin, and, if indicated, one or two additional FDA-approved medicines called anti-platelet drugs, guided by the results of TEG testing, may be better at preventing blood clots than our current standard of care.
Detailed description
This preliminary/pilot study involves a prospective, randomized, open-label, parallel group comparison of Denver Health's current standard of care for prevention of venous thromboembolism (VTE), commonly known as blood clots, using LMWH (Fragmin) 5000IU subcutaneously daily, with a thrombelastography (TEG)-guided, algorithm-based, individualized regimen of LMWH (Fragmin) plus/minus anti-platelet therapy (aspirin) guided by platelet mapping, in patients admitted to the SICU following trauma.
Approximately 50 trauma patients for whom prevention of VTE with LMWH is indicated, will be enrolled over a six month period.
The specific aims of this study are as follows:
- To determine the incidence of, and to characterize, hypercoagulability using TEG and conventional clinical coagulation testing (APTT, INR), Antithrombin III levels and Protein C activity.
- In the group of patients receiving LMWH (Fragmin) therapy alone for prevention of VTE:
- to assess the anticoagulant effect of standard LMWH (Fragmin) dosing (5000IU subcutaneously once daily) using TEG and Anti-Factor Xa level measurement, and
- to determine the extent of correlation of relevant TEG parameters with measured Anti-Factor Xa levels (U/ml).
- To assess whether TEG is a useful clinical tool for monitoring and optimizing prophylactic LMWH (Fragmin) therapy and for identifying the need for anti-platelet therapy to minimize the risk of VTE in these patients.
- To evaluate the clinical utility of platelet mapping for guiding anti-platelet therapy in those patients for whom it is indicated by TEG results.
- To determine the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in each randomized group and in the subgroup receiving anti-platelet therapy in addition to LMWH (Fragmin) for prevention of VTE.
The overall aim is to utilize the above data to evaluate a) the adequacy of our standard Fragmin dosing regimen (5000IU subcutaneously once daily) alone for prevention of VTE in our trauma/SICU patients, b) the need for anti-platelet agents in addition to LMWH (Fragmin) for prevention of VTE in our population, and c) to validate/further develop the TEG-guided algorithm for optimal prophylaxis of VTE using LMWH (Fragmin) plus/minus anti-platelet therapy guided by platelet mapping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (standard of care) | Active comparator | Drug: Dalteparin sodiumDalteparin sodium 5000IU subcutaneously daily |
| TEG-guided thromboprophylaxis | Experimental | Drug: Dalteparin sodium/aspirinDalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age at least 18 years,
- blunt or penetrating trauma requiring admission to the SICU
- requirement for LMWH (Fragmin) therapy for prophylaxis of VTE as standard of care, and
- informed consent by patient, legally authorized representative or proxy decision maker (if patient incompetent to provide) obtained and documented.
Key exclusion criteria (25 listed)
- known hypersensitivity to dalteparin sodium,
- known hypersensitivity to heparin or pork products,
- thrombocytopenia associated with positive tests for antiplatelet antibody in the presence of Fragmin,
- history of heparin-induced thrombocytopenia (HIT),
- chronic liver disease (bilirubin >2 mg/dl) or kidney insufficiency (CrCl <30mL/min),
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 |
|---|---|---|
| Dalteparin sodiumAlso: Dalteparin sodium (Fragmin)Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory | Drug | Control (standard of care) |
| Dalteparin sodium/aspirinAlso: dalteparin sodium (Fragmin)Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po. | Drug | TEG-guided thromboprophylaxis |
Primary outcome
Hypercoagulability
Time frame: Study day five.
To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.
Incidence of VTE
Time frame: Day 28 or discharge, whichever comes first.
The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)
8 secondary outcomes
TEG Parameters
Time frame: Study day five.
International Normalized Ratio (INR)
Time frame: Study day five.
Platelet Count
Time frame: Study day five.
TEG Parameters
Time frame: Study day five.
Conventional Coagulation Testing Parameters
Time frame: Study day five.
Conventional Coagulation Testing Parameters
Time frame: Study day five.
Conventional Coagulation Testing Parameters
Time frame: Study day five.
Conventional Coagulation Testing Parameters
Time frame: Study day five.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Ernest E. Moore Jr, M.D. principal investigator
Chief, Department of Surgery and Trauma Services , Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dalteparin sodium and Dalteparin sodium/aspirin in people with Venous Thromboembolism, run by Denver Health and Hospital Authority at 1 site in United States.
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 4 inclusion and 25 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: finished, as of the sponsor's last update on 8 Jan 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hypercoagulability (time frame: Study day five.). The study lists 2 primary outcomes in all. 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 8 Jan 2019.