Venous Thromboembolism Clinical Trial
— VTEPXOfficial 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
Verified date | December 2018 |
Source | Denver Health and Hospital Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: 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), - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health Medical Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Study day five. | |
Primary | 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) | Day 28 or discharge, whichever comes first. | |
Secondary | 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 a 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. |
Study day five. | |
Secondary | International Normalized Ratio (INR) | Plasma based conventional coagulation testing parameters | Study day five. | |
Secondary | Platelet Count | Platelet count measured by CBC test | Study day five. | |
Secondary | 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. |
Study day five. | |
Secondary | Conventional Coagulation Testing Parameters | Plasma based conventional coagulation testing parameters - Anti Xa | Study day five. | |
Secondary | Conventional Coagulation Testing Parameters | Plasma based conventional coagulation testing parameters - Fibrinogen | Study day five. | |
Secondary | Conventional Coagulation Testing Parameters | Plasma based conventional coagulation testing parameters - Anti-thrombin III | Study day five. | |
Secondary | Conventional Coagulation Testing Parameters | Plasma based conventional coagulation testing parameters - Protein C | Study day five. |
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