Thromboembolic ComplicationsNCT00990236
Thrombelastography Based Dosing of Enoxaparin
A study testing Enoxaparin dose adjusted Lovenox based on TEG and Enoxaparin 30 mg BID in people with Thromboembolic Complications, run by Oregon Health and Science University at 3 sites in United States.
Trial summary
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing clots in their legs or lungs. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Thromboembolic Complications
- What is being tested?
- Enoxaparin dose adjusted Lovenox based on TEG and Enoxaparin 30 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inpatient initiated on enoxaparin thromboprophylaxis
- Age greater than 15 years
Who cannot join
- Unable to obtain consent from patient or ARR
- Presence of: intracranial hemorrhage, brain injury
- Receiving therapeutic dose enoxaparin
- Receiving other forms of anticoagulation
- Receiving non-standard dosing regimen of enoxaparin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Health Science Center at Houston
Houston, Texas
Oregon Health & Science University
Portland, Oregon, 97239
University of Washington
Seattle, Washington
About this study
Official title: Thrombelastography Based Dosing of Enoxaparin for Thromboprophylaxis: a Prospective Randomized Trial
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not fully prevent the development of these clots especially in critically ill or obese patients. Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography (TEG®) can be used to measure how blood clots. The purposes of this study are:
- to learn if the TEG® can better guide physicians in prescribing an effective dose of Lovenox compared to standard doses recommended by the drug company in preventing blood clots from developing in the legs and lungs, and
- to compare the development of blood clots in patients receiving the standard dose of enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin.
- to determine if TEG guided dosing results in decreased bleeding complications compared to standard dosing.
Read the detailed description
Hypothesis:
Enoxaparin dosed to maintain a TEG® ΔR greater than 1.0 minute will decrease the incidence of DVT compared to standard dosing.
Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Once enrolled, the subject will be randomized to continue receiving standard dose enoxaparin (30 mg twice daily) or variable TEG® guided enoxaparin dosing. The treatment team and the subject will be blinded regarding the arm in which the patient is enrolled. Patient characteristics: age, gender, body mass index (BMI), comorbidities, Acute Physiology and Chronic Health Evaluation II score (APACHE II), injuries, and operations will be collected. As part of standard protocol in the ICU, all patients will undergo weekly ultrasound duplex examination of the lower extremities for presence of deep venous thrombosis.
A baseline TEG® will be completed on each patient when they are enrolled in the study. The blood will be drawn between four and six hours after the morning dose is administered, corresponding to maximum tissue levels of enoxaparin. TEG® assays will be run in duplicate for each patient, with and without heparinase, which negates the effects of enoxaparin in the assay.
Those patients randomized to the control arm of the study will have TEG® performed at baseline and daily for one week, then twice weekly. The twice weekly TEG® assays will be done until the patient is discharged from inpatient care or enoxaparin is discontinued by the treatment team. No adjustments will be made to their enoxaparin dosing.
Patients in the TEG® guided enoxaparin dosing arm will start treatment as ordered by the primary treatment team. After the second TEG®, the dose of enoxaparin will be adjusted in 10 mg increments per dose in order to reach a target ΔR between 1.0 and 1.4 minutes. If the initial ΔR is greater than 1.4 minutes, the dose of enoxaparin will be decreased by 10 mg increments until the target ΔR is achieved. Patients will have TEGs® performed daily and adjustment of dosing until the target ΔR is reached. Once the target ΔR is achieved, TEG® will be done twice weekly until the patient is discharged from inpatient care or enoxaparin is discontinued by the treatment team. All patients will be assessed daily by study personnel for bleeding complications. If bleeding complications occur, subjects will be withdrawn from the study. If interim analysis identifies a significant difference in bleeding complications between groups the study will be terminated.
- Conditions
- Thromboembolic Complications
- Being tested
- Enoxaparin dose adjusted Lovenox based on TEG, Enoxaparin 30 mg BID
- Keywords
- deep vein thrombosis, superficial venous thrombosis, pulmonary embolus
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin dose adjusted Lovenox based on TEGDrug
Also called enoxaparin, lovenox
Enoxaparin doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID.
Enoxaparin 30 mg BIDDrug
Also called enoxaparin, lovenox
Enoxaparin dose of 30 mg twice a day without any adjustments
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin 30 mg BID | Active comparator | standard dose enoxaparin thromboprophylaxis (30 mg twice daily) Receives: Drug: Enoxaparin 30 mg BID |
| Enoxaparin dose adjusted based on TEG | Experimental | enoxaparin dose modified based on TEG results Receives: Drug: Enoxaparin dose adjusted Lovenox based on TEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Deep Vein Thrombosis (DVT)
An ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.
Measured: Through study completion, assessed up to 120 days post randomization
Secondary outcomes (1)
Incidence of Bleeding Complications
An increase in bleeding complications will be assessed daily during hospitalization
Measured: Through study completion, assessed up to 120 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thromboembolic ComplicationsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Foundation, Oregon, National Trauma Research Institute
- Responsible party
- Principal investigator, Martin A Schreiber, MD, Oregon Health and Science University
- Investigators
- Martin Schreiber, MD FACS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990236
- Sponsor's protocol ID
- 001-01
- Status last verified
- Mar 2020
- First submitted
- 29 Sep 2009
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Connelly CR, Van PY, Hart KD, Louis SG, Fair KA, Erickson AS, Rick EA, Simeon EC, Bulger EM, Arbabi S, Holcomb JB, Moore LJ, Schreiber MA. Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial. JAMA Surg. 2016 Oct 19;151(10):e162069. doi: 10.1001/jamasurg.2016.2069. Epub 2016 Oct 19.
PubMed 27487253
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombelastography Based Dosing of Enoxaparin for Thromboprophylaxis: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00990236
- Acronym / sponsor ID
- 001-01
- Conditions
- Thromboembolic Complications
- Keywords
- deep vein thrombosis, superficial venous thrombosis, pulmonary embolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Medical Research Foundation, Oregon, National Trauma Research Institute
- Study start
- Sep 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox®) is given to patients who are at a higher risk of developing clots in their legs or lungs. Recent data suggest that a standard dose of Lovenox may not fully prevent the development of these clots especially in critically ill or obese patients. Routine enoxaparin dosing can also result in bleeding complications. Thrombelastography (TEG®) can be used to measure how blood clots. The purposes of this study are:
- to learn if the TEG® can better guide physicians in prescribing an effective dose of Lovenox compared to standard doses recommended by the drug company in preventing blood clots from developing in the legs and lungs, and
- to compare the development of blood clots in patients receiving the standard dose of enoxaparin compared to patients receiving a TEG® guided dose of enoxaparin.
- to determine if TEG guided dosing results in decreased bleeding complications compared to standard dosing.
Detailed description
Hypothesis:
Enoxaparin dosed to maintain a TEG® ΔR greater than 1.0 minute will decrease the incidence of DVT compared to standard dosing.
Initiation of enoxaparin thromboprophylaxis will be done by the treatment team. Once enrolled, the subject will be randomized to continue receiving standard dose enoxaparin (30 mg twice daily) or variable TEG® guided enoxaparin dosing. The treatment team and the subject will be blinded regarding the arm in which the patient is enrolled. Patient characteristics: age, gender, body mass index (BMI), comorbidities, Acute Physiology and Chronic Health Evaluation II score (APACHE II), injuries, and operations will be collected. As part of standard protocol in the ICU, all patients will undergo weekly ultrasound duplex examination of the lower extremities for presence of deep venous thrombosis.
A baseline TEG® will be completed on each patient when they are enrolled in the study. The blood will be drawn between four and six hours after the morning dose is administered, corresponding to maximum tissue levels of enoxaparin. TEG® assays will be run in duplicate for each patient, with and without heparinase, which negates the effects of enoxaparin in the assay.
Those patients randomized to the control arm of the study will have TEG® performed at baseline and daily for one week, then twice weekly. The twice weekly TEG® assays will be done until the patient is discharged from inpatient care or enoxaparin is discontinued by the treatment team. No adjustments will be made to their enoxaparin dosing.
Patients in the TEG® guided enoxaparin dosing arm will start treatment as ordered by the primary treatment team. After the second TEG®, the dose of enoxaparin will be adjusted in 10 mg increments per dose in order to reach a target ΔR between 1.0 and 1.4 minutes. If the initial ΔR is greater than 1.4 minutes, the dose of enoxaparin will be decreased by 10 mg increments until the target ΔR is achieved. Patients will have TEGs® performed daily and adjustment of dosing until the target ΔR is reached. Once the target ΔR is achieved, TEG® will be done twice weekly until the patient is discharged from inpatient care or enoxaparin is discontinued by the treatment team. All patients will be assessed daily by study personnel for bleeding complications. If bleeding complications occur, subjects will be withdrawn from the study. If interim analysis identifies a significant difference in bleeding complications between groups the study will be terminated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin 30 mg BID | Active comparator | Drug: Enoxaparin 30 mg BIDstandard dose enoxaparin thromboprophylaxis (30 mg twice daily) |
| Enoxaparin dose adjusted based on TEG | Experimental | Drug: Enoxaparin dose adjusted Lovenox based on TEGenoxaparin dose modified based on TEG results |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatient initiated on enoxaparin thromboprophylaxis
- Age greater than 15 years
Key exclusion criteria (5 listed)
- Unable to obtain consent from patient or ARR
- Presence of: intracranial hemorrhage, brain injury
- Receiving therapeutic dose enoxaparin
- Receiving other forms of anticoagulation
- Receiving non-standard dosing regimen of enoxaparin
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 |
|---|---|---|
| Enoxaparin dose adjusted Lovenox based on TEGAlso: enoxaparin, lovenoxEnoxaparin doses will be adjusted (10 mg BID) based on delta-R results from TEG. Delta-R < 1.0 min - increase dose by 10 mg BID; delta-R >/= 1.0 min and </= 2.0 min - no change; delta-R > 2.0 min - decrease dose by 10 mg BID. | Drug | Enoxaparin dose adjusted based on TEG |
| Enoxaparin 30 mg BIDAlso: enoxaparin, lovenoxEnoxaparin dose of 30 mg twice a day without any adjustments | Drug | Enoxaparin 30 mg BID |
Primary outcome
Development of Deep Vein Thrombosis (DVT)
Time frame: Through study completion, assessed up to 120 days post randomization
An ultrasound duplex will be completed at least one time after randomization to determine if the subject has developed a DVT.
1 secondary outcome
Incidence of Bleeding Complications
Time frame: Through study completion, assessed up to 120 days post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27487253Connelly CR, Van PY, Hart KD, Louis SG, Fair KA, Erickson AS, Rick EA, Simeon EC, Bulger EM, Arbabi S, Holcomb JB, Moore LJ, Schreiber MA. Thrombelastography-Based Dosing of Enoxaparin for Thromboprophylaxis in Trauma and Surgical Patients: A Randomized Clinical Trial. JAMA Surg. 2016 Oct 19;151(10):e162069. doi: 10.1001/jamasurg.2016.2069. Epub 2016 Oct 19.
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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.
Martin Schreiber, MD FACS principal investigator
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin dose adjusted Lovenox based on TEG and Enoxaparin 30 mg BID in people with Thromboembolic Complications, run by Oregon Health and Science University at 3 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Development of Deep Vein Thrombosis (DVT) (time frame: Through study completion, assessed up to 120 days post randomization). 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 NCT00990236, which also lists 1 linked publication.
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 3 Apr 2020.