NCT01916707

Brief Summary

Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To minimize the risk of these blood clots developing, patients may be given a blood-thinner drug such as enoxaparin. Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her weight. However, a recent study suggests that for obese patients, the set dose may be inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that is based on the patient's weight will help to prevent the formation of blood clots. The information gathered through this study will help doctors to understand the best way to prevent blood clots in future trauma patients. The potential risks of participating in this study include the minor risks of blood draws and ultrasounds, as well as the more significant risks of bleeding as a side effect of the enoxaparin.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

July 30, 2013

Last Update Submit

April 4, 2017

Conditions

Venous Thromboembolism

Keywords

traumaenoxaparinweight basedprophylaxis

Outcome Measures

Primary Outcomes (1)

  • Asymptomatic lower-extremity DVT identified during hospitalization

    Hospitalization

Secondary Outcomes (6)

  • Symptomatic lower extremity DVT during hospitalization and at 90 days

    90 Days

  • Asymptomatic proximal DVT during hospitalization

    Hospitalization

  • Symptomatic proximal DVT during hospitalization and at 90 days

    90 Days

  • Symptomatic upper-extremity DVT during hospitalization and at 90 days

    90 Days

  • Symptomatic PE during hospitalization and at 90 Days

    90 Days

  • +1 more secondary outcomes

Study Arms (2)

Standard Dosing

ACTIVE COMPARATOR

Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.

Drug: Dosing of enoxaparin for VTE prophylaxis

Weight Based Dosing

EXPERIMENTAL

Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.

Drug: Dosing of enoxaparin for VTE prophylaxis

Interventions

Dosing of enoxaparin for VTE prophylaxisDRUG
Standard DosingWeight Based Dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Body Weight \>60 kg
  • Admitted to the trauma services at Intermountain Medical Center
  • Have received 1 standard dose of enoxaparin for VTE prophylaxis during current hospital admission.

You may not qualify if:

  • Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician
  • Renal insufficiency (GFR \<30)
  • Platelet count \<100 thousand per cubic ml
  • Hypersensitivity to heparin or prior documented heparin induced thrombocytopenia (HIT) by patient report or in medical record
  • Pregnant or breast feeding
  • Hemorrhagic stroke in proceeding 3 months
  • abnormal baseline coagulation characterized by an INR \>1.4, obtained at the discretion of the treating clinician
  • Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
  • Treatment with concomitant antiplatelet agent other than aspirin 326 mg or more daily
  • Subjects with a life expectancy less than 1 month
  • Subjects hospitalized more than 72 hours prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157-7000, United States

Location

Related Publications (16)

  • Mosen D, Elliott CG, Egger MJ, Mundorff M, Hopkins J, Patterson R, Gardner RM. The effect of a computerized reminder system on the prevention of postoperative venous thromboembolism. Chest. 2004 May;125(5):1635-41. doi: 10.1378/chest.125.5.1635.

    PMID: 15136370BACKGROUND

  • Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.

    PMID: 15758007BACKGROUND

  • Goldhaber SZ, Dunn K, MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women's Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest. 2000 Dec;118(6):1680-4. doi: 10.1378/chest.118.6.1680.

    PMID: 11115458BACKGROUND

  • Khouli H, Shapiro J, Pham VP, Arfaei A, Esan O, Jean R, Homel P. Efficacy of deep venous thrombosis prophylaxis in the medical intensive care unit. J Intensive Care Med. 2006 Nov-Dec;21(6):352-8. doi: 10.1177/0885066606292880.

    PMID: 17095499BACKGROUND

  • Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.

    PMID: 16439370BACKGROUND

  • Samama MM, Cohen AT, Darmon JY, Desjardins L, Eldor A, Janbon C, Leizorovicz A, Nguyen H, Olsson CG, Turpie AG, Weisslinger N. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Engl J Med. 1999 Sep 9;341(11):793-800. doi: 10.1056/NEJM199909093411103.

    PMID: 10477777BACKGROUND

  • Leizorovicz A, Cohen AT, Turpie AG, Olsson CG, Vaitkus PT, Goldhaber SZ; PREVENT Medical Thromboprophylaxis Study Group. Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004 Aug 17;110(7):874-9. doi: 10.1161/01.CIR.0000138928.83266.24. Epub 2004 Aug 2.

    PMID: 15289368BACKGROUND

  • Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007 Feb 20;146(4):278-88. doi: 10.7326/0003-4819-146-4-200702200-00007.

    PMID: 17310052BACKGROUND

  • Francis CW. Clinical practice. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med. 2007 Apr 5;356(14):1438-44. doi: 10.1056/NEJMcp067264. No abstract available.

    PMID: 17409325BACKGROUND

  • Spyropoulos AC. Emerging strategies in the prevention of venous thromboembolism in hospitalized medical patients. Chest. 2005 Aug;128(2):958-69. doi: 10.1378/chest.128.2.958.

    PMID: 16100192BACKGROUND

  • Arnold DM, Kahn SR, Shrier I. Missed opportunities for prevention of venous thromboembolism: an evaluation of the use of thromboprophylaxis guidelines. Chest. 2001 Dec;120(6):1964-71. doi: 10.1378/chest.120.6.1964.

    PMID: 11742929BACKGROUND

  • Tapson VF, Decousus H, Pini M, Chong BH, Froehlich JB, Monreal M, Spyropoulos AC, Merli GJ, Zotz RB, Bergmann JF, Pavanello R, Turpie AG, Nakamura M, Piovella F, Kakkar AK, Spencer FA, Fitzgerald G, Anderson FA Jr; IMPROVE Investigators. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest. 2007 Sep;132(3):936-45. doi: 10.1378/chest.06-2993. Epub 2007 Jun 15.

    PMID: 17573514BACKGROUND

  • Kahn SR, Panju A, Geerts W, Pineo GF, Desjardins L, Turpie AG, Glezer S, Thabane L, Sebaldt RJ; CURVE study investigators. Multicenter evaluation of the use of venous thromboembolism prophylaxis in acutely ill medical patients in Canada. Thromb Res. 2007;119(2):145-55. doi: 10.1016/j.thromres.2006.01.011. Epub 2006 Mar 3.

    PMID: 16516275BACKGROUND

  • Freeman AL, Pendleton RC, Rondina MT. Prevention of venous thromboembolism in obesity. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1711-21. doi: 10.1586/erc.10.160.

    PMID: 21108553BACKGROUND

  • Rondina MT, Wheeler M, Rodgers GM, Draper L, Pendleton RC. Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients. Thromb Res. 2010 Mar;125(3):220-3. doi: 10.1016/j.thromres.2009.02.003. Epub 2009 Mar 9.

    PMID: 19272635BACKGROUND

  • Geerts WH, Jay RM, Code KI, Chen E, Szalai JP, Saibil EA, Hamilton PA. A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. N Engl J Med. 1996 Sep 5;335(10):701-7. doi: 10.1056/NEJM199609053351003.

    PMID: 8703169BACKGROUND

MeSH Terms

Conditions

Venous ThromboembolismWounds and Injuries

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 6, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(1)