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

NCT01050153 | Completed Results

• 1 other identifier: COMIRB # 09-0753
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Keywords

Prevention of venous thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (8)

• TEG Parameters

  Study day five.

• International Normalized Ratio (INR)

  Study day five.

• Platelet Count

  Study day five.

• TEG Parameters

  Study day five.

• Conventional Coagulation Testing Parameters

  Study day five.

Study Arms (2)

Control (standard of care)

ACTIVE COMPARATOR

Dalteparin sodium 5000IU subcutaneously daily

Drug: Dalteparin sodium

TEG-guided thromboprophylaxis

EXPERIMENTAL

Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm

Drug: Dalteparin sodium/aspirin

Interventions

Dalteparin sodium DRUG

Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory

Also known as: Dalteparin sodium (Fragmin)

Control (standard of care)

Dalteparin sodium/aspirin DRUG

Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily) po.

Also known as: dalteparin sodium (Fragmin)

TEG-guided thromboprophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Presence of any of the following relative contraindications to LMWH (Fragmin) therapy:
• new intracranial lesions, neoplasms or monitoring devices,
• extravascular thrombolytic therapy,

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Eisai Inc.: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80203, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Dalteparin; Aspirin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

1. lower than expected incidence of VTE events 2. Control group patients were followed for 5 days, while TEG-guided group was followed as long as in SICU 3. adherence to VTE prophylaxis with Daltaparin was significantly low in the TEG-guided group

Results Point of Contact

• Title: Ernest E. Moore
• Organization: Denver Health Medical Center

Ernest.Moore@dhha.org

303.602.1820

Study Officials

• Ernest E. Moore Jr, M.D.

  Chief, Department of Surgery and Trauma Services , Denver Health Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Surgery and Trauma Services Rocky Mountain Regional Trauma Center

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 8, 2019
• Results First Posted: April 25, 2014

Record last verified: 2018-12

Locations

US (1)