AnemiaNCT02651909
Utilization of TEG to Monitor Rivaroxaban Activity
An observational study of Anemia and Venous Thrombosis, run by Matthew Neal MD at 1 site in United States.
Trial summary
The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patients available as point-of-care testing. Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Venous Thrombosis
- What is being tested?
- blood sampling
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 4 Nov 2019
- Phase
- Observational
- 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
Study population: Patients that have taken the drug Rivaroxaban with-in the past 48hours that arrive in the ED with traumatic injury or with illness requiring emergent surgery
Who may be able to join
- Age ≥ 18 years
- Evidence of Rivaroxaban use with-in the last 48hours per medical records or report by patient, family, or other healthcare member familiar with patients drug medical history
- Willingness of subject or legally authorized representative to provide written consent for study procedures.
Who cannot join
- Known to be pregnant
- Known to be a prisoner
- Known Chronic liver disease
- Documented hypo coagulation condition (hemophilia, Von Willebrands, any congenital factor deficiency (V,X,XII) leukemia)
- Use of any anticoagulant medication other than Rivaroxaban (examples: Warfarin, lovenox, arixtra, fragmin, eliquis)
- Prehospital blood product administration (FFP, platelets, Prothrombin Complex Concentrate (PCC), tranexamic acid (TXA)
- Non-survivable traumatic brain Injury
- Comfort Measure Only (CMO) status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, PUH, 200 Lothrop Street
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Utilization of Thromboelastography to Monitor Rivaroxaban Activity in Trauma and Emergency Surgery Patients
The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
Read the detailed description
Rivaroxaban is a novel factor Xa inhibitor that is widely used for stroke prevention in nonvalvular atrial fibrillation, treatment of venous thromboembolism (VTE), and for VTE prophylaxis in patients undergoing knee or hip replacement surgery.
Current standard measurements of coagulation are relatively poor at reliably measuring detecting Rivaroxaban effects and more elaborate means of testing such as measurement of factor Xa activity are not immediately available so not useful in Urgent situations such as traumatic injury or emergent surgical indications. Due to the unmet need to devise a strategy for detecting Rivaroxaban activity in urgent situations, unnecessary reversal, which can lead to significant complications and cost, often results.
The investigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patient available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting Rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
This proposed study is a observational, prospective, cross sectional, study evaluating the Pharmacokinetics of rivaroxaban utilization thromboelastography (TEG) in a population of 80 trauma and emergency EGS patients who were taking rivaroxaban prior to admission and 20 active control trauma and EGS patients who were not taking rivaroxaban prior to admission (matched by age gender injury mechanism or illness)
Study activities:
Prior to any resuscitation with blood, blood products, or reversal agents, the investigators will obtain a TEG as well as standard coagulation testing: prothrombin time, partial thromboplastin time,international normalized ratio (PT/PTT/INR). TEG and coagulation studies will be obtained as soon as possible on admission and again following reversal of rivaroxaban (if reversed as SOC) or at 24 hours post admission to assess for changes.
To assess the efficacy of TEG in monitoring Rivaroxaban activity, the investigators will also perform a battery of coagulation tests at the same timepoints described above in order to attempt to assess the degree of functional factor X inhibition. The coagulation battery will include: thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, as well as the anti-factor Xa chromogenic assay (Rivaroxaban assay) run by our Institute for Transfusion Medicine.
TEG will be compared to these additional coagulation assays to determine whether prolongation of R time (the most sensitive measurement of coagulation factor activity) and other TEG parameters can be utilized as reliable measurements of Rivaroxaban activity. Each of these tests will be performed at the two aforementioned timepoints: admission and post reversal or 24 hours post admission if clinical team does not opt to reverse patent.
- Conditions
- Anemia, Venous Thrombosis
- Being tested
- blood sampling
- Medical subject headings
- Anemia, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling for TEG analysis, Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban Cohort | Evidence of Rivaroxaban use with-in the last 48hours Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay Receives: Other: blood sampling | |
| Control cohort not taking Rivaroxaban | Not taking Rivaroxaban - matched to Rivaroxaban group by age gender, type of injury or illness requiring urgent surgery Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients
To best observe inhibition of factor Xa, the investigators will perform kaolin TEGs as opposed to alternative forms of activated TEG (rapid-TEG) which may artificially induce coagulation and miss an effect on factor Xa activity. Additional TEG formats that may better target factor Xa inhibition will be investigated in parallel. As a control group, a second cohort of trauma and EGS patients (matched by demographics, injury mechanism, and illness) who are not taking Rivaroxaban will be identified. TEG and coagulation studies will be obtained on admission as described above. Following reversal of Rivaroxaban for subjects that a clinical decision is made to give reversal agents, or at 24 hours post admission for all other subjects, the TEG and PT/PTT/INR will be repeated to assess for changes in both groups.
Measured: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal
Secondary outcomes (1)
TEG as a point-of-care analysis following Rivaroxaban as compared to the standard of care measurement of coagulation.
To assess the efficacy of TEG in monitoring Rivaroxaban activity, the investigators will perform a battery of coagulation tests in order to attempt to assess the degree of functional factor X inhibition. The coagulation battery will include: thrombin time, thrombin generation, PT with neoplastine, INR, PTT, ecarin chromogenic assay, as well as the anti-factor Xa chromogenic assay (Rivaroxaban assay) run by the Institute for Transfusion Medicine at the University of Pittsburgh. TEG will be compared to these additional coagulation assays to determine whether prolongation of R time (the most sensitive measurement of coagulation factor activity) and other TEG parameters can be utilized as reliable measurements of Rivaroxaban activity. Each of these tests will be performed at the two aforementioned time points: admission and post-reversal/24 hours post admission
Measured: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion7 Jul 2018
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Neal MD
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor-investigator, Matthew Neal MD, University of Pittsburgh
- Investigators
- Matthew D Neal, MD, Principal investigator, University of Pittsburgh, Division of Trauma and Acute Care Surgery Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651909
- Sponsor's protocol ID
- PRO15050224
- Status last verified
- Nov 2019
- First submitted
- 15 Jun 2015
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Piccini JP, Hellkamp AS, Lokhnygina Y, Patel MR, Harrell FE, Singer DE, Becker RC, Breithardt G, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2014 Apr 22;3(2):e000521. doi: 10.1161/JAHA.113.000521.
PubMed 24755148Beyer-Westendorf J, Lutzner J, Donath L, Tittl L, Knoth H, Radke OC, Kuhlisch E, Stange T, Hartmann A, Gunther KP, Weiss N, Werth S. Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery: findings from the ORTHO-TEP registry. Thromb Haemost. 2013 Jan;109(1):154-63. doi: 10.1160/TH12-07-0510. Epub 2012 Nov 29.
PubMed 23197272Gordon JL, Fabian TC, Lee MD, Dugdale M. Anticoagulant and antiplatelet medications encountered in emergency surgery patients: a review of reversal strategies. J Trauma Acute Care Surg. 2013 Sep;75(3):475-86. doi: 10.1097/TA.0b013e3182a07391. No abstract available.
PubMed 24089118Holcomb JB, Minei KM, Scerbo ML, Radwan ZA, Wade CE, Kozar RA, Gill BS, Albarado R, McNutt MK, Khan S, Adams PR, McCarthy JJ, Cotton BA. Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department: experience with 1974 consecutive trauma patients. Ann Surg. 2012 Sep;256(3):476-86. doi: 10.1097/SLA.0b013e3182658180.
PubMed 22868371Muller MC, Meijers JC, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Crit Care. 2014 Feb 10;18(1):R30. doi: 10.1186/cc13721.
PubMed 24512650Bowry R, Fraser S, Archeval-Lao JM, Parker SA, Cai C, Rahbar MH, Grotta JC. Thrombelastography detects the anticoagulant effect of rivaroxaban in patients with stroke. Stroke. 2014 Mar;45(3):880-3. doi: 10.1161/STROKEAHA.113.004016. Epub 2014 Jan 14.
PubMed 24425115
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Thromboelastography to Monitor Rivaroxaban Activity in Trauma and Emergency Surgery Patients
- ClinicalTrials.gov ID
- NCT02651909
- Acronym / sponsor ID
- PRO15050224
- Conditions
- Anemia, Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Matthew Neal MDUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- Apr 2016
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 11 Jan 2016 (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.
The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
Detailed description
Rivaroxaban is a novel factor Xa inhibitor that is widely used for stroke prevention in nonvalvular atrial fibrillation, treatment of venous thromboembolism (VTE), and for VTE prophylaxis in patients undergoing knee or hip replacement surgery.
Current standard measurements of coagulation are relatively poor at reliably measuring detecting Rivaroxaban effects and more elaborate means of testing such as measurement of factor Xa activity are not immediately available so not useful in Urgent situations such as traumatic injury or emergent surgical indications. Due to the unmet need to devise a strategy for detecting Rivaroxaban activity in urgent situations, unnecessary reversal, which can lead to significant complications and cost, often results.
The investigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patient available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting Rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
This proposed study is a observational, prospective, cross sectional, study evaluating the Pharmacokinetics of rivaroxaban utilization thromboelastography (TEG) in a population of 80 trauma and emergency EGS patients who were taking rivaroxaban prior to admission and 20 active control trauma and EGS patients who were not taking rivaroxaban prior to admission (matched by age gender injury mechanism or illness)
Study activities:
Prior to any resuscitation with blood, blood products, or reversal agents, the investigators will obtain a TEG as well as standard coagulation testing: prothrombin time, partial thromboplastin time,international normalized ratio (PT/PTT/INR). TEG and coagulation studies will be obtained as soon as possible on admission and again following reversal of rivaroxaban (if reversed as SOC) or at 24 hours post admission to assess for changes.
To assess the efficacy of TEG in monitoring Rivaroxaban activity, the investigators will also perform a battery of coagulation tests at the same timepoints described above in order to attempt to assess the degree of functional factor X inhibition. The coagulation battery will include: thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, as well as the anti-factor Xa chromogenic assay (Rivaroxaban assay) run by our Institute for Transfusion Medicine.
TEG will be compared to these additional coagulation assays to determine whether prolongation of R time (the most sensitive measurement of coagulation factor activity) and other TEG parameters can be utilized as reliable measurements of Rivaroxaban activity. Each of these tests will be performed at the two aforementioned timepoints: admission and post reversal or 24 hours post admission if clinical team does not opt to reverse patent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban Cohort | – | Other: blood samplingEvidence of Rivaroxaban use with-in the last 48hours Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay |
| Control cohort not taking Rivaroxaban | – | Other: blood samplingNot taking Rivaroxaban - matched to Rivaroxaban group by age gender, type of injury or illness requiring urgent surgery Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have taken the drug Rivaroxaban with-in the past 48hours that arrive in the ED with traumatic injury or with illness requiring emergent surgery
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Evidence of Rivaroxaban use with-in the last 48hours per medical records or report by patient, family, or other healthcare member familiar with patients drug medical history
- Willingness of subject or legally authorized representative to provide written consent for study procedures.
Key exclusion criteria (8 listed)
- Known to be pregnant
- Known to be a prisoner
- Known Chronic liver disease
- Documented hypo coagulation condition (hemophilia, Von Willebrands, any congenital factor deficiency (V,X,XII) leukemia)
- Use of any anticoagulant medication other than Rivaroxaban (examples: Warfarin, lovenox, arixtra, fragmin, eliquis)
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 |
|---|---|---|
| blood samplingblood sampling for TEG analysis, Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay | Other | Control cohort not taking Rivaroxaban, Rivaroxaban Cohort |
Primary outcome
Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients
Time frame: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal
To best observe inhibition of factor Xa, the investigators will perform kaolin TEGs as opposed to alternative forms of activated TEG (rapid-TEG) which may artificially induce coagulation and miss an effect on factor Xa activity. Additional TEG formats that may better target factor Xa inhibition will be investigated in parallel. As a control group, a second cohort of trauma and EGS patients (matched by demographics, injury mechanism, and illness) who are not taking Rivaroxaban will be identified. TEG and coagulation studies will be obtained on admission as described above. Following reversal of Rivaroxaban for subjects that a clinical decision is made to give reversal agents, or at 24 hours post admission for all other subjects, the TEG and PT/PTT/INR will be repeated to assess for changes in both groups.
1 secondary outcome
TEG as a point-of-care analysis following Rivaroxaban as compared to the standard of care measurement of coagulation.
Time frame: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 24755148Piccini JP, Hellkamp AS, Lokhnygina Y, Patel MR, Harrell FE, Singer DE, Becker RC, Breithardt G, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2014 Apr 22;3(2):e000521. doi: 10.1161/JAHA.113.000521.
- Background: PubMed 23197272Beyer-Westendorf J, Lutzner J, Donath L, Tittl L, Knoth H, Radke OC, Kuhlisch E, Stange T, Hartmann A, Gunther KP, Weiss N, Werth S. Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery: findings from the ORTHO-TEP registry. Thromb Haemost. 2013 Jan;109(1):154-63. doi: 10.1160/TH12-07-0510. Epub 2012 Nov 29.
- Background: PubMed 24089118Gordon JL, Fabian TC, Lee MD, Dugdale M. Anticoagulant and antiplatelet medications encountered in emergency surgery patients: a review of reversal strategies. J Trauma Acute Care Surg. 2013 Sep;75(3):475-86. doi: 10.1097/TA.0b013e3182a07391. No abstract available.
- Background: PubMed 22868371Holcomb JB, Minei KM, Scerbo ML, Radwan ZA, Wade CE, Kozar RA, Gill BS, Albarado R, McNutt MK, Khan S, Adams PR, McCarthy JJ, Cotton BA. Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department: experience with 1974 consecutive trauma patients. Ann Surg. 2012 Sep;256(3):476-86. doi: 10.1097/SLA.0b013e3182658180.
- Background: PubMed 24512650Muller MC, Meijers JC, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Crit Care. 2014 Feb 10;18(1):R30. doi: 10.1186/cc13721.
- Background: PubMed 24425115Bowry R, Fraser S, Archeval-Lao JM, Parker SA, Cai C, Rahbar MH, Grotta JC. Thrombelastography detects the anticoagulant effect of rivaroxaban in patients with stroke. Stroke. 2014 Mar;45(3):880-3. doi: 10.1161/STROKEAHA.113.004016. Epub 2014 Jan 14.
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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.
Matthew D Neal, MD principal investigator
University of Pittsburgh, Division of Trauma and Acute Care Surgery Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Venous Thrombosis, run by Matthew Neal MD 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 3 inclusion and 8 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 8 Nov 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients (time frame: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal). 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 NCT02651909, which also lists 6 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 8 Nov 2019.