The Clinical Utility of Thrombelastography in Guiding Prophylaxis of Venous Thromboembolism Following Trauma

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Collaborator: Eisai Inc.
• Treatments: Aspirin; Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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.