Venous ThromboembolismPhase 4WeBETNCT01916707
Weight Based Enoxaparin in Trauma Patients
A Phase 4 study testing Dosing of enoxaparin for VTE prophylaxis in people with Venous Thromboembolism, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. 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?
- Dosing of enoxaparin for VTE prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 18 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Murray, Utah, 84157-7000
About this study
Official title: Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients
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.
- Conditions
- Venous Thromboembolism
- Being tested
- Dosing of enoxaparin for VTE prophylaxis
- Keywords
- trauma, enoxaparin, weight based, prophylaxis
- Medical subject headings
- Venous Thromboembolism, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosing of enoxaparin for VTE prophylaxisDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard Dosing | Active comparator | Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours. Receives: Drug: Dosing of enoxaparin for VTE prophylaxis |
| Weight Based Dosing | Experimental | Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours. Receives: Drug: Dosing of enoxaparin for VTE prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic lower-extremity DVT identified during hospitalization
Measured: Hospitalization
Secondary outcomes (6)
Symptomatic lower extremity DVT during hospitalization and at 90 days
Measured: 90 Days
Asymptomatic proximal DVT during hospitalization
Measured: Hospitalization
Symptomatic proximal DVT during hospitalization and at 90 days
Measured: 90 Days
Symptomatic upper-extremity DVT during hospitalization and at 90 days
Measured: 90 Days
Symptomatic PE during hospitalization and at 90 Days
Measured: 90 Days
Major Bleeding
Major Bleeding as defined by the criteria of the International Society of Thrombosis.
Measured: Hospitalization and at 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916707
- Sponsor's protocol ID
- WEBet-664-1a
- Acronym
- WeBET
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15136370Kucher 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.
PubMed 15758007Goldhaber 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.
PubMed 11115458Khouli 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.
PubMed 17095499Cohen 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.
PubMed 16439370Samama 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.
PubMed 10477777Leizorovicz 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.
PubMed 15289368Dentali 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.
PubMed 17310052Francis 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.
PubMed 17409325Spyropoulos 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.
PubMed 16100192Arnold 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.
PubMed 11742929Tapson 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.
PubMed 17573514Kahn 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.
PubMed 16516275Freeman 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.
PubMed 21108553Rondina 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.
PubMed 19272635
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients
- ClinicalTrials.gov ID
- NCT01916707
- Acronym / sponsor ID
- WeBET / WEBet-664-1a
- Conditions
- Venous Thromboembolism
- Keywords
- trauma, enoxaparin, weight based, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dosing | Active comparator | Drug: Dosing of enoxaparin for VTE prophylaxisPatients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours. |
| Weight Based Dosing | Experimental | Drug: Dosing of enoxaparin for VTE prophylaxisPatients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Dosing of enoxaparin for VTE prophylaxis | Drug | Standard Dosing, Weight Based Dosing |
Primary outcome
Asymptomatic lower-extremity DVT identified during hospitalization
Time frame: Hospitalization
6 secondary outcomes
Symptomatic lower extremity DVT during hospitalization and at 90 days
Time frame: 90 Days
Asymptomatic proximal DVT during hospitalization
Time frame: Hospitalization
Symptomatic proximal DVT during hospitalization and at 90 days
Time frame: 90 Days
Symptomatic upper-extremity DVT during hospitalization and at 90 days
Time frame: 90 Days
Symptomatic PE during hospitalization and at 90 Days
Time frame: 90 Days
Major Bleeding
Time frame: Hospitalization and at 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Background: PubMed 15136370Mosen 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.
- Background: PubMed 15758007Kucher 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.
- Background: PubMed 11115458Goldhaber 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.
- Background: PubMed 17095499Khouli 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.
- Background: PubMed 16439370Cohen 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.
- Background: PubMed 10477777Samama 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.
- Background: PubMed 15289368Leizorovicz 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.
- Background: PubMed 17310052Dentali 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.
- Background: PubMed 17409325Francis 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.
- Background: PubMed 16100192Spyropoulos 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.
- Background: PubMed 11742929Arnold 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.
- Background: PubMed 17573514Tapson 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dosing of enoxaparin for VTE prophylaxis in people with Venous Thromboembolism, run by Intermountain Health Care, Inc. 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 11 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: status not confirmed, as of the sponsor's last update on 5 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Asymptomatic lower-extremity DVT identified during hospitalization (time frame: Hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916707, which also lists 16 linked publications.
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 5 Apr 2017.