Postoperative; Dysfunction Following Cardiac SurgeryFORCAST6NCT02832427
Is Six Weeks Too Long for First Outpatient Review After Cardiac Surgery?
An observational study of Postoperative; Dysfunction Following Cardiac Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Although the first outpatient review following cardiac surgery is conventionally scheduled for six weeks after hospital discharge, there is no evidence to support this practice. Thirty-day mortality and morbidity rates, which are now widely used as indicators of the quality of surgical care, reveal rates that are… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to May 2017
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing coronary artery bypass grafting and/or valve surgery
Who may be able to join
- Adult patients undergoing coronary artery bypass and/or valve surgery.
- Patients who can read and write in English
Who cannot join
- Postoperative stroke with neurologic deficit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Hull, East Yorkshire, HU16 5JQ
About this study
Official title: The First Planned Outpatient Review After Cardiac Surgery: Is Six Weeks Too Long?
Although the first outpatient review following cardiac surgery is conventionally scheduled for six weeks after hospital discharge, there is no evidence to support this practice. Thirty-day mortality and morbidity rates, which are now widely used as indicators of the quality of surgical care, reveal rates that are higher than corresponding in-hospital rates. Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not known. The objectives of our study are to determine the postoperative mortality and morbidity rates in the 6-week interval between hospital discharge and the first planned specialist review after cardiac surgery, and to assess the level of patient satisfaction with current practice.
The study will enrol eligible patients who are undergoing elective and urgent coronary artery bypass and/or valve surgery at our institution over a 6-month period and provide them with study information. Prior to discharge after surgery, prospective participants will be consented and given a questionnaire to take home, complete and bring along to the outpatient appointment.
Read more
The investigators will analyse the data to determine the rates and timing of the complications, and the impact on postoperative recovery. The investigators will also assess the level of patient satisfaction with the current practice.
Appropriate conclusions either in support of current practice or, a change in practice would be drawn..
Read the detailed description
Rationale and Background In current practice, patients who have undergone cardiac surgery return to the outpatient clinic for their first postoperative review by the specialist team, six weeks after hospital discharge. However, there is no evidence to show that this is the optimal interval before these patients with ongoing risks of postoperative complications are reviewed. Not infrequently, after hospital discharge, cardiac surgery patients make unplanned hospital visits and/or require readmission during the 6-week wait for outpatient review due to surgery-related complications [1-3]. Whereas it is well established that 30-day mortality and morbidity rates after surgery are in excess of the corresponding in-hospital rates [4], the 42-day incidence of these postoperative complications before outpatient review, is not known. In fact the 30-day readmission and mortality rates are widely used as indicators of the quality of surgical care [5, 6], and 30-day hospital readmission rates after cardiac surgery as high as 49% has been reported [7]. It can be argued the long interval between hospital discharge and the first outpatient specialist review exposes patients to ongoing risks which explain the higher rates of surgery-related complications over time. Postoperative programmes that have incorporated cardiac surgery nurse home visits before outpatient review report significant reduction in hospital readmissions [8].
Hospital readmissions contribute significantly to healthcare costs whilst compromising the quality of care [9, 10]. As a result strategies directed at reducing 30-day adverse outcomes and readmissions have focussed on the identification of predictors of readmission and their management [11-16]. The risk factors identified older age and co-morbidities which are prevalent among patients undergoing cardiac surgery in the current era; an even stronger reason to re-examine the long-standing outpatient follow-up practice.
The purpose of this prospective observational study will be to assess the burden of postoperative mortality and morbidity in the 6-week interval between hospital discharge and the first planned outpatient review after cardiac surgery. This data will be helpful in determining if the current timing of follow-up review should be revised.
The proposed study, will seek to answer these questions and provide scientific evidence to support clinical practice.
Study goals and objectives After hospital discharge, patients who have undergone cardiac surgery still develop complications which can impair their recovery and sometimes require unplanned visits to accident and emergency departments, and hospital admissions.
The main study goal is to define the magnitude of ongoing postoperative complications suffered by discharged cardiac surgery patients before their first planned review.
Study design The study is a prospective observational study that will involve administering a questionnaire to consecutive adult patients who will undergone coronary artery bypass and/or valve surgery at our institution over a 6-month period.
Methodology On admission for surgery, eligible participants will be approached and provided with study information. Prior to discharge after surgery, prospective participants will be consented and given the study questionnaire to take home to complete themselves or by their spouse/carer.
Preoperative and peri-operative data will be collected using the standard cardiothoracic surgery electronic database programme (Patient Analysis and Tracking System), as is routine at the investigators' institution. In addition, post discharge data relating to planned and unplanned hospital attendance and/or admission, and any intervention by General Practitioner/Practice nurse during the 6 week interval before the first planned specialist review, shall be prospectively collected using the study questionnaire.
Statistical analyses The data obtained from the study questionnaire will be linked with the peri-operative data in the cardiothoracic database, managed by dedicated and specially trained staff. The database is password-protected and access to the data is restricted.
The data will be anonymised and the variables coded for statistical analyses. The analyses will include the determination of rates of different complications and the impact on the postoperative recovery. The timing of the complications/intervention will be represented on a frequency plot.
Results The study findings will be discussed at local and international scientific meetings and published in specialty journals.
The result will be used to generate hypothesis to support the application for a randomised clinical trial.
- Keywords
- Coronary artery bypass grafting, Heart valve surgery, Postoperative morbidity, Operative mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with postoperative mortality, or complications who require further interventions and hospital readmission .
Patients who require further interventions and hospital readmission.
Measured: 6 weeks
Secondary outcomes (1)
The timing of postoperative mortality
The postoperative mortality of patients.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
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 Postoperative; Dysfunction Following Cardiac SurgeryStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dumbor Ngaage, MS, FRCS, Principal investigator, Castle Hill Hospital, Kingston-Upon-Hull, HU16 5JQ, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832427
- Sponsor's protocol ID
- 203366
- Acronym
- FORCAST6
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Publications
Shroyer AL, Coombs LP, Peterson ED, Eiken MC, DeLong ER, Chen A, Ferguson TB Jr, Grover FL, Edwards FH; Society of Thoracic Surgeons. The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models. Ann Thorac Surg. 2003 Jun;75(6):1856-64; discussion 1864-5. doi: 10.1016/s0003-4975(03)00179-6.
PubMed 12822628Fox JP, Suter LG, Wang K, Wang Y, Krumholz HM, Ross JS. Hospital-based, acute care use among patients within 30 days of discharge after coronary artery bypass surgery. Ann Thorac Surg. 2013 Jul;96(1):96-104. doi: 10.1016/j.athoracsur.2013.03.091. Epub 2013 May 21.
PubMed 23702228Hannan EL, Zhong Y, Lahey SJ, Culliford AT, Gold JP, Smith CR, Higgins RS, Jordan D, Wechsler A. 30-day readmissions after coronary artery bypass graft surgery in New York State. JACC Cardiovasc Interv. 2011 May;4(5):569-76. doi: 10.1016/j.jcin.2011.01.010.
PubMed 21596331Siregar S, Groenwold RH, de Mol BA, Speekenbrink RG, Versteegh MI, Brandon Bravo Bruinsma GJ, Bots ML, van der Graaf Y, van Herwerden LA. Evaluation of cardiac surgery mortality rates: 30-day mortality or longer follow-up? Eur J Cardiothorac Surg. 2013 Nov;44(5):875-83. doi: 10.1093/ejcts/ezt119. Epub 2013 Mar 7.
PubMed 23471150Hwang YJ, Minnillo BJ, Kim SP, Abouassaly R. Assessment of healthcare quality metrics: Length-of-stay, 30-day readmission, and 30-day mortality for radical nephrectomy with inferior vena cava thrombectomy. Can Urol Assoc J. 2015 Mar-Apr;9(3-4):114-21. doi: 10.5489/cuaj.2547.
PubMed 26085868Shih T, Dimick JB. Reliability of readmission rates as a hospital quality measure in cardiac surgery. Ann Thorac Surg. 2014 Apr;97(4):1214-8. doi: 10.1016/j.athoracsur.2013.11.048. Epub 2014 Feb 1.
PubMed 24492060Lahey SJ, Campos CT, Jennings B, Pawlow P, Stokes T, Levitsky S. Hospital readmission after cardiac surgery. Does "fast track" cardiac surgery result in cost saving or cost shifting? Circulation. 1998 Nov 10;98(19 Suppl):II35-40.
PubMed 9852877Hall MH, Esposito RA, Pekmezaris R, Lesser M, Moravick D, Jahn L, Blenderman R, Akerman M, Nouryan CN, Hartman AR. Cardiac surgery nurse practitioner home visits prevent coronary artery bypass graft readmissions. Ann Thorac Surg. 2014 May;97(5):1488-93; discussion 1493-5. doi: 10.1016/j.athoracsur.2013.12.049. Epub 2014 Mar 6.
PubMed 24612701Lawson EH, Hall BL, Louie R, Ettner SL, Zingmond DS, Han L, Rapp M, Ko CY. Association between occurrence of a postoperative complication and readmission: implications for quality improvement and cost savings. Ann Surg. 2013 Jul;258(1):10-8. doi: 10.1097/SLA.0b013e31828e3ac3.
PubMed 23579579Wick EC, Shore AD, Hirose K, Ibrahim AM, Gearhart SL, Efron J, Weiner JP, Makary MA. Readmission rates and cost following colorectal surgery. Dis Colon Rectum. 2011 Dec;54(12):1475-9. doi: 10.1097/DCR.0b013e31822ff8f0.
PubMed 22067174Stewart RD, Campos CT, Jennings B, Lollis SS, Levitsky S, Lahey SJ. Predictors of 30-day hospital readmission after coronary artery bypass. Ann Thorac Surg. 2000 Jul;70(1):169-74. doi: 10.1016/s0003-4975(00)01386-2.
PubMed 10921703Hannan EL, Racz MJ, Walford G, Ryan TJ, Isom OW, Bennett E, Jones RH. Predictors of readmission for complications of coronary artery bypass graft surgery. JAMA. 2003 Aug 13;290(6):773-80. doi: 10.1001/jama.290.6.773.
PubMed 12915430Price JD, Romeiser JL, Gnerre JM, Shroyer AL, Rosengart TK. Risk analysis for readmission after coronary artery bypass surgery: developing a strategy to reduce readmissions. J Am Coll Surg. 2013 Mar;216(3):412-9. doi: 10.1016/j.jamcollsurg.2012.11.009. Epub 2013 Jan 11.
PubMed 23313544Billah B, Reid CM, Shardey GC, Smith JA. A preoperative risk prediction model for 30-day mortality following cardiac surgery in an Australian cohort. Eur J Cardiothorac Surg. 2010 May;37(5):1086-92. doi: 10.1016/j.ejcts.2009.11.021. Epub 2010 Feb 8.
PubMed 20117015Lancaster E, Postel M, Satou N, Shemin R, Benharash P. Introspection into institutional database allows for focused quality improvement plan in cardiac surgery: example for a new global healthcare system. Am Surg. 2013 Oct;79(10):1040-4.
PubMed 24160795
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Planned Outpatient Review After Cardiac Surgery: Is Six Weeks Too Long?
- ClinicalTrials.gov ID
- NCT02832427
- Acronym / sponsor ID
- FORCAST6 / 203366
- Keywords
- Coronary artery bypass grafting, Heart valve surgery, Postoperative morbidity, Operative mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Jul 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.
Although the first outpatient review following cardiac surgery is conventionally scheduled for six weeks after hospital discharge, there is no evidence to support this practice. Thirty-day mortality and morbidity rates, which are now widely used as indicators of the quality of surgical care, reveal rates that are higher than corresponding in-hospital rates. Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not known. The objectives of our study are to determine the postoperative mortality and morbidity rates in the 6-week interval between hospital discharge and the first planned specialist review after cardiac surgery, and to assess the level of patient satisfaction with current practice.
The study will enrol eligible patients who are undergoing elective and urgent coronary artery bypass and/or valve surgery at our institution over a 6-month period and provide them with study information. Prior to discharge after surgery, prospective participants will be consented and given a questionnaire to take home, complete and bring along to the outpatient appointment.
The investigators will analyse the data to determine the rates and timing of the complications, and the impact on postoperative recovery. The investigators will also assess the level of patient satisfaction with the current practice.
Appropriate conclusions either in support of current practice or, a change in practice would be drawn..
Detailed description
Rationale and Background In current practice, patients who have undergone cardiac surgery return to the outpatient clinic for their first postoperative review by the specialist team, six weeks after hospital discharge. However, there is no evidence to show that this is the optimal interval before these patients with ongoing risks of postoperative complications are reviewed. Not infrequently, after hospital discharge, cardiac surgery patients make unplanned hospital visits and/or require readmission during the 6-week wait for outpatient review due to surgery-related complications [1-3]. Whereas it is well established that 30-day mortality and morbidity rates after surgery are in excess of the corresponding in-hospital rates [4], the 42-day incidence of these postoperative complications before outpatient review, is not known. In fact the 30-day readmission and mortality rates are widely used as indicators of the quality of surgical care [5, 6], and 30-day hospital readmission rates after cardiac surgery as high as 49% has been reported [7]. It can be argued the long interval between hospital discharge and the first outpatient specialist review exposes patients to ongoing risks which explain the higher rates of surgery-related complications over time. Postoperative programmes that have incorporated cardiac surgery nurse home visits before outpatient review report significant reduction in hospital readmissions [8].
Hospital readmissions contribute significantly to healthcare costs whilst compromising the quality of care [9, 10]. As a result strategies directed at reducing 30-day adverse outcomes and readmissions have focussed on the identification of predictors of readmission and their management [11-16]. The risk factors identified older age and co-morbidities which are prevalent among patients undergoing cardiac surgery in the current era; an even stronger reason to re-examine the long-standing outpatient follow-up practice.
The purpose of this prospective observational study will be to assess the burden of postoperative mortality and morbidity in the 6-week interval between hospital discharge and the first planned outpatient review after cardiac surgery. This data will be helpful in determining if the current timing of follow-up review should be revised.
The proposed study, will seek to answer these questions and provide scientific evidence to support clinical practice.
Study goals and objectives After hospital discharge, patients who have undergone cardiac surgery still develop complications which can impair their recovery and sometimes require unplanned visits to accident and emergency departments, and hospital admissions.
The main study goal is to define the magnitude of ongoing postoperative complications suffered by discharged cardiac surgery patients before their first planned review.
Study design The study is a prospective observational study that will involve administering a questionnaire to consecutive adult patients who will undergone coronary artery bypass and/or valve surgery at our institution over a 6-month period.
Methodology On admission for surgery, eligible participants will be approached and provided with study information. Prior to discharge after surgery, prospective participants will be consented and given the study questionnaire to take home to complete themselves or by their spouse/carer.
Preoperative and peri-operative data will be collected using the standard cardiothoracic surgery electronic database programme (Patient Analysis and Tracking System), as is routine at the investigators' institution. In addition, post discharge data relating to planned and unplanned hospital attendance and/or admission, and any intervention by General Practitioner/Practice nurse during the 6 week interval before the first planned specialist review, shall be prospectively collected using the study questionnaire.
Statistical analyses The data obtained from the study questionnaire will be linked with the peri-operative data in the cardiothoracic database, managed by dedicated and specially trained staff. The database is password-protected and access to the data is restricted.
The data will be anonymised and the variables coded for statistical analyses. The analyses will include the determination of rates of different complications and the impact on the postoperative recovery. The timing of the complications/intervention will be represented on a frequency plot.
Results The study findings will be discussed at local and international scientific meetings and published in specialty journals.
The result will be used to generate hypothesis to support the application for a randomised clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing coronary artery bypass grafting and/or valve surgery
Key inclusion criteria (2 listed)
- Adult patients undergoing coronary artery bypass and/or valve surgery.
- Patients who can read and write in English
Key exclusion criteria (1 listed)
- Postoperative stroke with neurologic deficit
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 proportion of participants with postoperative mortality, or complications who require further interventions and hospital readmission .
Time frame: 6 weeks
Patients who require further interventions and hospital readmission.
1 secondary outcome
The timing of postoperative mortality
Time frame: 6 weeks
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 12 Jul 2019.
- Background: PubMed 12822628Shroyer AL, Coombs LP, Peterson ED, Eiken MC, DeLong ER, Chen A, Ferguson TB Jr, Grover FL, Edwards FH; Society of Thoracic Surgeons. The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models. Ann Thorac Surg. 2003 Jun;75(6):1856-64; discussion 1864-5. doi: 10.1016/s0003-4975(03)00179-6.
- Background: PubMed 23702228Fox JP, Suter LG, Wang K, Wang Y, Krumholz HM, Ross JS. Hospital-based, acute care use among patients within 30 days of discharge after coronary artery bypass surgery. Ann Thorac Surg. 2013 Jul;96(1):96-104. doi: 10.1016/j.athoracsur.2013.03.091. Epub 2013 May 21.
- Background: PubMed 21596331Hannan EL, Zhong Y, Lahey SJ, Culliford AT, Gold JP, Smith CR, Higgins RS, Jordan D, Wechsler A. 30-day readmissions after coronary artery bypass graft surgery in New York State. JACC Cardiovasc Interv. 2011 May;4(5):569-76. doi: 10.1016/j.jcin.2011.01.010.
- Background: PubMed 23471150Siregar S, Groenwold RH, de Mol BA, Speekenbrink RG, Versteegh MI, Brandon Bravo Bruinsma GJ, Bots ML, van der Graaf Y, van Herwerden LA. Evaluation of cardiac surgery mortality rates: 30-day mortality or longer follow-up? Eur J Cardiothorac Surg. 2013 Nov;44(5):875-83. doi: 10.1093/ejcts/ezt119. Epub 2013 Mar 7.
- Background: PubMed 26085868Hwang YJ, Minnillo BJ, Kim SP, Abouassaly R. Assessment of healthcare quality metrics: Length-of-stay, 30-day readmission, and 30-day mortality for radical nephrectomy with inferior vena cava thrombectomy. Can Urol Assoc J. 2015 Mar-Apr;9(3-4):114-21. doi: 10.5489/cuaj.2547.
- Background: PubMed 24492060Shih T, Dimick JB. Reliability of readmission rates as a hospital quality measure in cardiac surgery. Ann Thorac Surg. 2014 Apr;97(4):1214-8. doi: 10.1016/j.athoracsur.2013.11.048. Epub 2014 Feb 1.
- Background: PubMed 9852877Lahey SJ, Campos CT, Jennings B, Pawlow P, Stokes T, Levitsky S. Hospital readmission after cardiac surgery. Does "fast track" cardiac surgery result in cost saving or cost shifting? Circulation. 1998 Nov 10;98(19 Suppl):II35-40.
- Background: PubMed 24612701Hall MH, Esposito RA, Pekmezaris R, Lesser M, Moravick D, Jahn L, Blenderman R, Akerman M, Nouryan CN, Hartman AR. Cardiac surgery nurse practitioner home visits prevent coronary artery bypass graft readmissions. Ann Thorac Surg. 2014 May;97(5):1488-93; discussion 1493-5. doi: 10.1016/j.athoracsur.2013.12.049. Epub 2014 Mar 6.
- Background: PubMed 23579579Lawson EH, Hall BL, Louie R, Ettner SL, Zingmond DS, Han L, Rapp M, Ko CY. Association between occurrence of a postoperative complication and readmission: implications for quality improvement and cost savings. Ann Surg. 2013 Jul;258(1):10-8. doi: 10.1097/SLA.0b013e31828e3ac3.
- Background: PubMed 22067174Wick EC, Shore AD, Hirose K, Ibrahim AM, Gearhart SL, Efron J, Weiner JP, Makary MA. Readmission rates and cost following colorectal surgery. Dis Colon Rectum. 2011 Dec;54(12):1475-9. doi: 10.1097/DCR.0b013e31822ff8f0.
- Background: PubMed 10921703Stewart RD, Campos CT, Jennings B, Lollis SS, Levitsky S, Lahey SJ. Predictors of 30-day hospital readmission after coronary artery bypass. Ann Thorac Surg. 2000 Jul;70(1):169-74. doi: 10.1016/s0003-4975(00)01386-2.
- Background: PubMed 12915430Hannan EL, Racz MJ, Walford G, Ryan TJ, Isom OW, Bennett E, Jones RH. Predictors of readmission for complications of coronary artery bypass graft surgery. JAMA. 2003 Aug 13;290(6):773-80. doi: 10.1001/jama.290.6.773.
- Publication LinkLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
Related trials for Postoperative; Dysfunction Following Cardiac Surgery
Not yet recruitingObservational study
Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery
Organ Dysfunction, Inflammation in Cardiac Surgery
Not yet recruitingObservational study
PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery
Not yet recruiting
Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery
Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction
Not yet recruitingObservational study
Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Perioperative Bleeding, Coagulopathy During Cardiac Surgery
Not yet recruiting
FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy
Pulmonary Dysfunction, Median Sternotomy Recovery
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.
Dumbor Ngaage, MS, FRCS principal investigator
Castle Hill Hospital, Kingston-Upon-Hull, HU16 5JQ, UK
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 Postoperative; Dysfunction Following Cardiac Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 1 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 12 Jul 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 Kingdom. 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 proportion of participants with postoperative mortality, or complications who require further interventions and hospital readmission . (time frame: 6 weeks). 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 NCT02832427, 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 12 Jul 2019.