Pulmonary EmbolismTELOSNCT01908231
Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in 2 countries.
Trial summary
To prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 330 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2012to Feb 2014
- 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: Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 day or more before inclusion. The diagnosis of PE will be established by spiral computed tomography or by lung scan or a selective pulmonary angiogram. Patients with proven PE who will give written consent to the use of their medical information for research purposes will be enrolled in the study.
Who may be able to join
- Symptomatic objective pulmonary embolism
Who cannot join
- life expectancies of less than 3 months
- first symptoms 15 day or more before inclusion.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites
Azienda Ospedaliero Universitaria Careggi, Emergency Department
Florence, 50134
Presidio Ospedaliero Livorno
Livorno
Azienda ospedaliera universitaria San Giovanni Battista (Molinette)
Torino
Spain1 site
Respiratory Department and Medicine Department, Ramón y Cajal Hospital and Alcalá de Henares University
Madrid
About this study
Official title: Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism: the Thrombo-Embolism Lactate Outcome Study
To prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE.
Read the detailed description
Pulmonary embolism (PE) represents 0.4% of hospitalizations and is the third leading cause of death due to cardiovascular disease (1). In contrast to stroke and acute coronary syndromes, its mortality has not decreased in recent decades likely due to only minor advances in short-term prognostication and treatment strategies (2).The presence of shock or hypotension remains the principal prognostic clinical marker and,to date, is the only factor that clearly indicates a more aggressive treatment than heparin (3). However, only 5% of patients with acute PE present with shock. The majority of PE patients are normotensive and are usually treated with heparin alone. Several studies have looked for new prognostic indicators in order to better stratify normotensive PE patients. A large body of evidence shows that right ventricular dysfunction/injury markers such as elevation of brain natriuretic peptides, troponins, and echocardiographic evidence of right ventricular dysfunction (RVD) are associated with adverse prognosis (3-8). However, these markers have some important limitations. Echocardiography is usually not available around-the-clock in most clinical settings, moreover it shares with troponins and natriuretic peptides a good negative predictive value (>90%) but a low positive predictive value (about 10%) for short-term mortality, probably precluding these markers' usefulness to target more aggressive treatments (8).
Plasma lactate concentration is a marker of the severity of the tissue oxygen supply-to-demand imbalance. It may reflect tissue hypoperfusion also in the presence of normal blood pressure. Accordingly, in other critical settings such as sepsis,plasma lactate concentration is considered to be an accurate prognostic marker as it rises before hemodynamic impairment is clinically evident (9). Furthermore, plasma lactate concentration can be easily and rapidly assayed on arterial blood samples using a blood gas analyzer, which is usually available in emergency departments (EDs) and intensive care units. Recently, a retrospective study showed that plasma lactate ≥ 2 mmol/L was associated with a high mortality rate in patients with acute PE (10). Moreover a prospective monocentric study confirmed these retrospective results and revealed that plasma lactate has prognostic relevance beyond known clinical and instrumental prognostic markers (TELOS study, Ann Emerg Med, in press, see attached file)
The aim of present study is to prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE. In particular, we examine whether high plasma lactate (≥ 2 mmol/L) is associated with a high incidence of PE related major adverse events, defined as PE related death or hemodynamic collapse >10% within 7 days of follow-up. Moreover we investigate whether plasma lactate shows incremental prognostic value to clinically overt hemodynamic impairment and to RVD/injury markers, maintaining prognostic relevance in both hypotensive and normotensive PE patients.
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, plasma lactate, right ventricular dysfunction
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Embolism | Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 days or more before inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of PE related death or hemodynamic collapse
PE related death was defined as a fatal event occurring in the hours after clinical deterioration due to PE, including an objectively diagnosed recurrent PE, or if death could not be attributed to a documented cause and PE could not be confidently ruled out. Autopsy is not mandatory.
Hemodynamic collapse is defined as at least 1 of the following: (i) the need for cardiopulmonary resuscitation; (ii) systolic blood pressure <90 mm Hg for at least 15 minutes, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 minutes, with signs of end-organ hypoperfusion (cold extremities, or urinary output <30 mL/h, or mental confusion); (iii) the need for catecholamines (except for dopamine at a rate of < 5 μg kg-1 min-1) to maintain adequate organ perfusion and a systolic blood pressure of >90 mm Hg; (iiii) the need for invasive or noninvasive mechanical ventilation; (iiiii) imaging-confirmed symptomatic recurrence of PE within 7 days.
Measured: 7 days.
Secondary outcomes (2)
all cause death
Measured: 30 days
PE recurrence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Stefano Grifoni, MD, Study chair, Emergency department, Azienda Ospedaliero Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908231
- Sponsor's protocol ID
- 0313
- Acronym
- TELOS
- Status last verified
- Feb 2014
- First submitted
- 23 Jul 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pulido T, Aranda A, Zevallos MA, Bautista E, Martinez-Guerra ML, Santos LE, Sandoval J. Pulmonary embolism as a cause of death in patients with heart disease: an autopsy study. Chest. 2006 May;129(5):1282-7. doi: 10.1378/chest.129.5.1282.
PubMed 16685020Burge AJ, Freeman KD, Klapper PJ, Haramati LB. Increased diagnosis of pulmonary embolism without a corresponding decline in mortality during the CT era. Clin Radiol. 2008 Apr;63(4):381-6. doi: 10.1016/j.crad.2007.10.004. Epub 2007 Dec 21.
PubMed 18325357Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
PubMed 18757870Grifoni S, Olivotto I, Cecchini P, Pieralli F, Camaiti A, Santoro G, Conti A, Agnelli G, Berni G. Short-term clinical outcome of patients with acute pulmonary embolism, normal blood pressure, and echocardiographic right ventricular dysfunction. Circulation. 2000 Jun 20;101(24):2817-22. doi: 10.1161/01.cir.101.24.2817.
PubMed 10859287Kucher N, Goldhaber SZ. Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism. Circulation. 2003 Nov 4;108(18):2191-4. doi: 10.1161/01.CIR.0000100687.99687.CE. No abstract available.
PubMed 14597581Kline JA, Zeitouni R, Marchick MR, Hernandez-Nino J, Rose GA. Comparison of 8 biomarkers for prediction of right ventricular hypokinesis 6 months after submassive pulmonary embolism. Am Heart J. 2008 Aug;156(2):308-14. doi: 10.1016/j.ahj.2008.03.026. Epub 2008 Jun 18.
PubMed 18657661Binder L, Pieske B, Olschewski M, Geibel A, Klostermann B, Reiner C, Konstantinides S. N-terminal pro-brain natriuretic peptide or troponin testing followed by echocardiography for risk stratification of acute pulmonary embolism. Circulation. 2005 Sep 13;112(11):1573-9. doi: 10.1161/CIRCULATIONAHA.105.552216. Epub 2005 Sep 6.
PubMed 16144990Shapiro NI, Trzeciak S, Hollander JE, Birkhahn R, Otero R, Osborn TM, Moretti E, Nguyen HB, Gunnerson KJ, Milzman D, Gaieski DF, Goyal M, Cairns CB, Ngo L, Rivers EP. A prospective, multicenter derivation of a biomarker panel to assess risk of organ dysfunction, shock, and death in emergency department patients with suspected sepsis. Crit Care Med. 2009 Jan;37(1):96-104. doi: 10.1097/CCM.0b013e318192fd9d.
PubMed 19050610Vanni S, Socci F, Pepe G, Nazerian P, Viviani G, Baioni M, Conti A, Grifoni S. High plasma lactate levels are associated with increased risk of in-hospital mortality in patients with pulmonary embolism. Acad Emerg Med. 2011 Aug;18(8):830-5. doi: 10.1111/j.1553-2712.2011.01128.x.
PubMed 21843218Vanni S, Polidori G, Vergara R, Pepe G, Nazerian P, Moroni F, Garbelli E, Daviddi F, Grifoni S. Prognostic value of ECG among patients with acute pulmonary embolism and normal blood pressure. Am J Med. 2009 Mar;122(3):257-64. doi: 10.1016/j.amjmed.2008.08.031.
PubMed 19272487Grifoni S, Vanni S, Magazzini S, Olivotto I, Conti A, Zanobetti M, Polidori G, Pieralli F, Peiman N, Becattini C, Agnelli G. Association of persistent right ventricular dysfunction at hospital discharge after acute pulmonary embolism with recurrent thromboembolic events. Arch Intern Med. 2006 Oct 23;166(19):2151-6. doi: 10.1001/archinte.166.19.2151.
PubMed 17060547
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism: the Thrombo-Embolism Lactate Outcome Study
- ClinicalTrials.gov ID
- NCT01908231
- Acronym / sponsor ID
- TELOS / 0313
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, plasma lactate, right ventricular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Jul 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.
To prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE.
Detailed description
Pulmonary embolism (PE) represents 0.4% of hospitalizations and is the third leading cause of death due to cardiovascular disease (1). In contrast to stroke and acute coronary syndromes, its mortality has not decreased in recent decades likely due to only minor advances in short-term prognostication and treatment strategies (2).The presence of shock or hypotension remains the principal prognostic clinical marker and,to date, is the only factor that clearly indicates a more aggressive treatment than heparin (3). However, only 5% of patients with acute PE present with shock. The majority of PE patients are normotensive and are usually treated with heparin alone. Several studies have looked for new prognostic indicators in order to better stratify normotensive PE patients. A large body of evidence shows that right ventricular dysfunction/injury markers such as elevation of brain natriuretic peptides, troponins, and echocardiographic evidence of right ventricular dysfunction (RVD) are associated with adverse prognosis (3-8). However, these markers have some important limitations. Echocardiography is usually not available around-the-clock in most clinical settings, moreover it shares with troponins and natriuretic peptides a good negative predictive value (>90%) but a low positive predictive value (about 10%) for short-term mortality, probably precluding these markers' usefulness to target more aggressive treatments (8).
Plasma lactate concentration is a marker of the severity of the tissue oxygen supply-to-demand imbalance. It may reflect tissue hypoperfusion also in the presence of normal blood pressure. Accordingly, in other critical settings such as sepsis,plasma lactate concentration is considered to be an accurate prognostic marker as it rises before hemodynamic impairment is clinically evident (9). Furthermore, plasma lactate concentration can be easily and rapidly assayed on arterial blood samples using a blood gas analyzer, which is usually available in emergency departments (EDs) and intensive care units. Recently, a retrospective study showed that plasma lactate ≥ 2 mmol/L was associated with a high mortality rate in patients with acute PE (10). Moreover a prospective monocentric study confirmed these retrospective results and revealed that plasma lactate has prognostic relevance beyond known clinical and instrumental prognostic markers (TELOS study, Ann Emerg Med, in press, see attached file)
The aim of present study is to prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE. In particular, we examine whether high plasma lactate (≥ 2 mmol/L) is associated with a high incidence of PE related major adverse events, defined as PE related death or hemodynamic collapse >10% within 7 days of follow-up. Moreover we investigate whether plasma lactate shows incremental prognostic value to clinically overt hemodynamic impairment and to RVD/injury markers, maintaining prognostic relevance in both hypotensive and normotensive PE patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Embolism | – | –Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 days or more before inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 day or more before inclusion. The diagnosis of PE will be established by spiral computed tomography or by lung scan or a selective pulmonary angiogram. Patients with proven PE who will give written consent to the use of their medical information for research purposes will be enrolled in the study.
Key inclusion criteria (1 listed)
- Symptomatic objective pulmonary embolism
Key exclusion criteria (2 listed)
- life expectancies of less than 3 months
- first symptoms 15 day or more before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The composite of PE related death or hemodynamic collapse
Time frame: 7 days.
PE related death was defined as a fatal event occurring in the hours after clinical deterioration due to PE, including an objectively diagnosed recurrent PE, or if death could not be attributed to a documented cause and PE could not be confidently ruled out. Autopsy is not mandatory. Hemodynamic collapse is defined as at least 1 of the following: (i) the need for cardiopulmonary resuscitation; (ii) systolic blood pressure <90 mm Hg for at least 15 minutes, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 minutes, with signs of end-organ hypoperfusion (cold extremities, or urinary output <30 mL/h, or mental confusion); (iii) the need for catecholamines (except for dopamine at a rate of < 5 μg kg-1 min-1) to maintain adequate organ perfusion and a systolic blood pressure of >90 mm Hg; (iiii) the need for invasive or noninvasive mechanical ventilation; (iiiii) imaging-confirmed symptomatic recurrence of PE within 7 days.
2 secondary outcomes
all cause death
Time frame: 30 days
PE recurrence
Time frame: 30 days
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 19 Feb 2014.
- Background: PubMed 16685020Pulido T, Aranda A, Zevallos MA, Bautista E, Martinez-Guerra ML, Santos LE, Sandoval J. Pulmonary embolism as a cause of death in patients with heart disease: an autopsy study. Chest. 2006 May;129(5):1282-7. doi: 10.1378/chest.129.5.1282.
- Background: PubMed 18325357Burge AJ, Freeman KD, Klapper PJ, Haramati LB. Increased diagnosis of pulmonary embolism without a corresponding decline in mortality during the CT era. Clin Radiol. 2008 Apr;63(4):381-6. doi: 10.1016/j.crad.2007.10.004. Epub 2007 Dec 21.
- Background: PubMed 18757870Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
- Background: PubMed 10859287Grifoni S, Olivotto I, Cecchini P, Pieralli F, Camaiti A, Santoro G, Conti A, Agnelli G, Berni G. Short-term clinical outcome of patients with acute pulmonary embolism, normal blood pressure, and echocardiographic right ventricular dysfunction. Circulation. 2000 Jun 20;101(24):2817-22. doi: 10.1161/01.cir.101.24.2817.
- Background: PubMed 14597581Kucher N, Goldhaber SZ. Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism. Circulation. 2003 Nov 4;108(18):2191-4. doi: 10.1161/01.CIR.0000100687.99687.CE. No abstract available.
- Background: PubMed 18657661Kline JA, Zeitouni R, Marchick MR, Hernandez-Nino J, Rose GA. Comparison of 8 biomarkers for prediction of right ventricular hypokinesis 6 months after submassive pulmonary embolism. Am Heart J. 2008 Aug;156(2):308-14. doi: 10.1016/j.ahj.2008.03.026. Epub 2008 Jun 18.
- Background: PubMed 16144990Binder L, Pieske B, Olschewski M, Geibel A, Klostermann B, Reiner C, Konstantinides S. N-terminal pro-brain natriuretic peptide or troponin testing followed by echocardiography for risk stratification of acute pulmonary embolism. Circulation. 2005 Sep 13;112(11):1573-9. doi: 10.1161/CIRCULATIONAHA.105.552216. Epub 2005 Sep 6.
- Background: PubMed 19050610Shapiro NI, Trzeciak S, Hollander JE, Birkhahn R, Otero R, Osborn TM, Moretti E, Nguyen HB, Gunnerson KJ, Milzman D, Gaieski DF, Goyal M, Cairns CB, Ngo L, Rivers EP. A prospective, multicenter derivation of a biomarker panel to assess risk of organ dysfunction, shock, and death in emergency department patients with suspected sepsis. Crit Care Med. 2009 Jan;37(1):96-104. doi: 10.1097/CCM.0b013e318192fd9d.
- Background: PubMed 21843218Vanni S, Socci F, Pepe G, Nazerian P, Viviani G, Baioni M, Conti A, Grifoni S. High plasma lactate levels are associated with increased risk of in-hospital mortality in patients with pulmonary embolism. Acad Emerg Med. 2011 Aug;18(8):830-5. doi: 10.1111/j.1553-2712.2011.01128.x.
- Background: PubMed 19272487Vanni S, Polidori G, Vergara R, Pepe G, Nazerian P, Moroni F, Garbelli E, Daviddi F, Grifoni S. Prognostic value of ECG among patients with acute pulmonary embolism and normal blood pressure. Am J Med. 2009 Mar;122(3):257-64. doi: 10.1016/j.amjmed.2008.08.031.
- Background: PubMed 17060547Grifoni S, Vanni S, Magazzini S, Olivotto I, Conti A, Zanobetti M, Polidori G, Pieralli F, Peiman N, Becattini C, Agnelli G. Association of persistent right ventricular dysfunction at hospital discharge after acute pulmonary embolism with recurrent thromboembolic events. Arch Intern Med. 2006 Oct 23;166(19):2151-6. doi: 10.1001/archinte.166.19.2151.
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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.
Stefano Grifoni, MD study chair
Emergency department, Azienda Ospedaliero Universitaria Careggi
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in 2 countries.
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 1 inclusion and 2 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Spain. 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?
The composite of PE related death or hemodynamic collapse (time frame: 7 days.). 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 NCT01908231, which also lists 11 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 19 Feb 2014.