Venous ThromboembolismPhase 2NCT03212365
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
A Phase 2 study testing Fixed dose and Variable dose in people with Venous Thromboembolism and Deep Venous Thrombosis, run by University of Utah at 2 sites in United States.
Trial summary
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus
- What is being tested?
- Fixed dose and Variable dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jul 2017to 1 Oct 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving plastic and reconstructive surgery under general anesthesis
- Expected post-operative stay of 2 days or more
Who cannot join
- Contraindication to use of enoxaparin
- intracranial bleeding/stroke
- Hematoma or bleeding disorder
- Heparin-induced thrmbocytopenia positive
- Creatinine clearance less than or equal to 30 mL/min
- Serum creatinine greater than 1.6 mg/dL
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- epidural anesthesia
- patients placed on non-enoxaparin chemoprophylaxis regimens
- gross weight exceeding 150kg
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84132
Stanford University
Stanford, California, 94305
About this study
Official title: Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Read the detailed description
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
- Being tested
- Fixed dose, Variable dose
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed doseDrug
Participants will receive 40 mg enoxaparin twice daily
Variable doseDrug
Participants will receive 0.5mg/kg enoxaparin twice daily
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose | Other | Participants will receive 40 mg enoxaparin twice daily Receives: Drug: Fixed dose |
| Variable Dose | Experimental | Participants will receive 0.5mg/kg enoxaparin twice daily Receives: Drug: Variable dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL)
Measured: Four hours following third enoxaparin dose
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL)
Measured: Four hours following third enoxaparin dose
Secondary outcomes (2)
Percentage of Participants With Venous Thromboembolism Events
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Measured: 90 days
Percentage of Patients With Bleeding Events
Bleeding events requiring alteration in the course of care within 90 days of surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start3 Jul 2017
- Primary completion2 Jun 2019
- Study completion1 Oct 2019
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 Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Christopher Pannucci, University of Utah
- Investigators
- Christopher Puccini, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212365
- Sponsor's protocol ID
- 100416
- Status last verified
- Aug 2020
- First submitted
- 6 Jul 2017
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 Oct 19.
PubMed 33086312
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens
- ClinicalTrials.gov ID
- NCT03212365
- Acronym / sponsor ID
- 100416
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Detailed description
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose | Other | Drug: Fixed doseParticipants will receive 40 mg enoxaparin twice daily |
| Variable Dose | Experimental | Drug: Variable doseParticipants will receive 0.5mg/kg enoxaparin twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- receiving plastic and reconstructive surgery under general anesthesis
- Expected post-operative stay of 2 days or more
Key exclusion criteria (9 listed)
- Contraindication to use of enoxaparin
- intracranial bleeding/stroke
- Hematoma or bleeding disorder
- Heparin-induced thrmbocytopenia positive
- Creatinine clearance less than or equal to 30 mL/min
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 |
|---|---|---|
| Fixed doseParticipants will receive 40 mg enoxaparin twice daily | Drug | Fixed Dose |
| Variable doseParticipants will receive 0.5mg/kg enoxaparin twice daily | Drug | Variable Dose |
Primary outcome
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
Time frame: Four hours following third enoxaparin dose
Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL)
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
Time frame: Four hours following third enoxaparin dose
Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL)
2 secondary outcomes
Percentage of Participants With Venous Thromboembolism Events
Time frame: 90 days
Percentage of Patients With Bleeding Events
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33086312Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 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.
Christopher Puccini, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fixed dose and Variable dose in people with Venous Thromboembolism and Deep Venous Thrombosis, run by University of Utah at 2 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 9 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 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?
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL) (time frame: Four hours following third enoxaparin dose). The study lists 2 primary outcomes in all. 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 NCT03212365, 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 16 Sep 2020.