EndocarditisENDO_AUMCNCT05139589
The ENDOCARDITIS AUMC Data Collection
An observational study of Endocarditis and Coagulation Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Coagulation Disorder, Valve Disease, Heart
- What is being tested?
- None, observational
- How many people
- 3,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2023to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will consist of two groups (a study group and a control group) of male and female patients, 18 years and older. The study group consists of all patients with infective endocarditis admitted to the Amsterdam UMC, in either location. Endocarditis patients undergoing valve surgery will also be compared to patients undergoing similar surgery for non-infectious reasons (control group).
Who may be able to join
- Patients > 18 years
- Dutch or English speaking
- All patients with infective endocarditis admitted to Amsterdam UMC in the study period
- All patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in Amsterdam UMC in the same period
Who cannot join
- Previous history of coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Jennifer S Breel, MPA,MSc., +316 1001 9257, j.s.breel@amsterdamumc.nl
Henning Hermanns, MD, PhD, +31205669111 ext. 62533, h.hermanns@amsterdamumc.nl
About this study
Official title: The ENDOCARDITIS AUMC Data Collection : a Matched Cohort Study on Perioperative Coagulation in Conservatively and Surgically Treated Patients With Valvular Dysfunction, With and Without Infective Endocarditis
The investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.
Read the detailed description
The aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. In addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. The investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing IE. The investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year.
These outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.
- Conditions
- Endocarditis, Coagulation Disorder, Valve Disease, Heart
- Being tested
- None, observational
- Medical subject headings
- Endocarditis, Hemostatic Disorders, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, observationalOther
Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Infective endocarditis, surgical arm | Patients with infective endocardits requiring valve surgery Receives: Other: None, observational | |
| Infective endocarditis, conservative arm | Patients with infective endocardits, not requiring valve surgery Receives: Other: None, observational | |
| Valve disease, heart, surgically repaired | Patients requiring valve surgery Receives: Other: None, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic complications
Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)
Measured: up to 1 year
Secondary outcomes (2)
Incidence of perioperative coagulation abnormalities
How often perioperative coagulation abnormalities, measured by classical laboratory values and rotational thromboelastometry are seen from diagnosis to 24 hours post-surgery
Measured: First 24 hours after surgery
Differences in incidence of pathogens and the relation with disease severity
To evaluate the effect of different pathogens (evaluated by laboratory results) on the clinical status
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 Aug 2023 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for EndocarditisStudies 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
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus W Hollmann, MD,PhD,PhD, Principal investigator, Amsterdam Academic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139589
- Sponsor's protocol ID
- W21_466#21.518
- Acronym
- ENDO_AUMC
- Status last verified
- Jul 2023
- First submitted
- 30 Nov 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murdoch DR, Corey GR, Hoen B, Miro JM, Fowler VG Jr, Bayer AS, Karchmer AW, Olaison L, Pappas PA, Moreillon P, Chambers ST, Chu VH, Falco V, Holland DJ, Jones P, Klein JL, Raymond NJ, Read KM, Tripodi MF, Utili R, Wang A, Woods CW, Cabell CH; International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS) Investigators. Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study. Arch Intern Med. 2009 Mar 9;169(5):463-73. doi: 10.1001/archinternmed.2008.603.
PubMed 19273776Pant S, Patel NJ, Deshmukh A, Golwala H, Patel N, Badheka A, Hirsch GA, Mehta JL. Trends in infective endocarditis incidence, microbiology, and valve replacement in the United States from 2000 to 2011. J Am Coll Cardiol. 2015 May 19;65(19):2070-6. doi: 10.1016/j.jacc.2015.03.518.
PubMed 25975469Cahill TJ, Prendergast BD. Infective endocarditis. Lancet. 2016 Feb 27;387(10021):882-93. doi: 10.1016/S0140-6736(15)00067-7. Epub 2015 Sep 1.
PubMed 26341945Durante-Mangoni E, Molaro R, Iossa D. The role of hemostasis in infective endocarditis. Curr Infect Dis Rep. 2014 Nov;16(11):435. doi: 10.1007/s11908-014-0435-8.
PubMed 25230604Prendergast BD, Tornos P. Surgery for infective endocarditis: who and when? Circulation. 2010 Mar 9;121(9):1141-52. doi: 10.1161/CIRCULATIONAHA.108.773598. No abstract available.
PubMed 20212293Buyukasyk NS, Ileri M, Alper A, Senen K, Atak R, Hisar I, Yetkin E, Turhan H, Demirkan D. Increased blood coagulation and platelet activation in patients with infective endocarditis and embolic events. Clin Cardiol. 2004 Mar;27(3):154-8. doi: 10.1002/clc.4960270312.
PubMed 15049384Na S, Shim JK, Chun DH, Kim DH, Hong SW, Kwak YL. Stabilized infective endocarditis and altered heparin responsiveness during cardiopulmonary bypass. World J Surg. 2009 Sep;33(9):1862-7. doi: 10.1007/s00268-009-0107-2.
PubMed 19597879Thota R, Ganti AK, Subbiah S. Apparent heparin resistance in a patient with infective endocarditis secondary to elevated factor VIII levels. J Thromb Thrombolysis. 2012 Jul;34(1):132-4. doi: 10.1007/s11239-012-0692-z.
PubMed 22302637Yu S, Khalpey ZI, Wong RK, Huynh T, Nielsen VG. Complete antithrombin replacement for anticoagulation for cardiopulmonary bypass to repair severe infective mitral valve endocarditis. Blood Coagul Fibrinolysis. 2018 Jan;29(1):123-125. doi: 10.1097/MBC.0000000000000668.
PubMed 28957943Ileri M, Alper A, Senen K, Durmaz T, Atak R, Hisar I, Yetkin E, Turhan H, Demirkan D. Effect of infective endocarditis on blood coagulation and platelet activation and comparison of patients with to those without embolic events. Am J Cardiol. 2003 Mar 15;91(6):689-92. doi: 10.1016/s0002-9149(02)03405-7.
PubMed 12633799Salis S, Mazzanti VV, Merli G, Salvi L, Tedesco CC, Veglia F, Sisillo E. Cardiopulmonary bypass duration is an independent predictor of morbidity and mortality after cardiac surgery. J Cardiothorac Vasc Anesth. 2008 Dec;22(6):814-22. doi: 10.1053/j.jvca.2008.08.004. Epub 2008 Oct 22.
PubMed 18948034Salsano A, Giacobbe DR, Sportelli E, Olivieri GM, Natali R, Prevosto M, Del Bono V, Viscoli C, Santini F. Aortic cross-clamp time and cardiopulmonary bypass time: prognostic implications in patients operated on for infective endocarditis. Interact Cardiovasc Thorac Surg. 2018 Sep 1;27(3):328-335. doi: 10.1093/icvts/ivy085.
PubMed 29579243Dahn H, Buth K, Legare JF, Mingo H, Kent B, Whynot S, Scheffler M. Endocarditis is not an Independent Predictor of Blood Transfusion in Aortic Valve Replacement Patients With Severe Aortic Regurgitation. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):687-91. doi: 10.1053/j.jvca.2015.10.003. Epub 2015 Oct 9.
PubMed 26750645Deppe AC, Weber C, Zimmermann J, Kuhn EW, Slottosch I, Liakopoulos OJ, Choi YH, Wahlers T. Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res. 2016 Jun 15;203(2):424-33. doi: 10.1016/j.jss.2016.03.008. Epub 2016 Mar 26.
PubMed 27363652
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENDOCARDITIS AUMC Data Collection : a Matched Cohort Study on Perioperative Coagulation in Conservatively and Surgically Treated Patients With Valvular Dysfunction, With and Without Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05139589
- Acronym / sponsor ID
- ENDO_AUMC / W21_466#21.518
- Conditions
- Endocarditis, Coagulation Disorder, Valve Disease, Heart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 6 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Dec 2021 (actual)
- 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 investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.
Detailed description
The aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. In addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. The investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing IE. The investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year.
These outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infective endocarditis, surgical arm | – | Other: None, observationalPatients with infective endocardits requiring valve surgery |
| Infective endocarditis, conservative arm | – | Other: None, observationalPatients with infective endocardits, not requiring valve surgery |
| Valve disease, heart, surgically repaired | – | Other: None, observationalPatients requiring valve surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of two groups (a study group and a control group) of male and female patients, 18 years and older. The study group consists of all patients with infective endocarditis admitted to the Amsterdam UMC, in either location. Endocarditis patients undergoing valve surgery will also be compared to patients undergoing similar surgery for non-infectious reasons (control group).
Key inclusion criteria (4 listed)
- Patients > 18 years
- Dutch or English speaking
- All patients with infective endocarditis admitted to Amsterdam UMC in the study period
- All patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in Amsterdam UMC in the same period
Key exclusion criteria (1 listed)
- Previous history of coagulation disorders
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 |
|---|---|---|
| None, observationalPatients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery | Other | Infective endocarditis, conservative arm, Infective endocarditis, surgical arm, Valve disease, heart, surgically repaired |
Primary outcome
Thromboembolic complications
Time frame: up to 1 year
Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)
2 secondary outcomes
Incidence of perioperative coagulation abnormalities
Time frame: First 24 hours after surgery
Differences in incidence of pathogens and the relation with disease severity
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 19273776Murdoch DR, Corey GR, Hoen B, Miro JM, Fowler VG Jr, Bayer AS, Karchmer AW, Olaison L, Pappas PA, Moreillon P, Chambers ST, Chu VH, Falco V, Holland DJ, Jones P, Klein JL, Raymond NJ, Read KM, Tripodi MF, Utili R, Wang A, Woods CW, Cabell CH; International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS) Investigators. Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study. Arch Intern Med. 2009 Mar 9;169(5):463-73. doi: 10.1001/archinternmed.2008.603.
- Background: PubMed 25975469Pant S, Patel NJ, Deshmukh A, Golwala H, Patel N, Badheka A, Hirsch GA, Mehta JL. Trends in infective endocarditis incidence, microbiology, and valve replacement in the United States from 2000 to 2011. J Am Coll Cardiol. 2015 May 19;65(19):2070-6. doi: 10.1016/j.jacc.2015.03.518.
- Background: PubMed 26341945Cahill TJ, Prendergast BD. Infective endocarditis. Lancet. 2016 Feb 27;387(10021):882-93. doi: 10.1016/S0140-6736(15)00067-7. Epub 2015 Sep 1.
- Background: PubMed 25230604Durante-Mangoni E, Molaro R, Iossa D. The role of hemostasis in infective endocarditis. Curr Infect Dis Rep. 2014 Nov;16(11):435. doi: 10.1007/s11908-014-0435-8.
- Background: PubMed 20212293Prendergast BD, Tornos P. Surgery for infective endocarditis: who and when? Circulation. 2010 Mar 9;121(9):1141-52. doi: 10.1161/CIRCULATIONAHA.108.773598. No abstract available.
- Background: PubMed 15049384Buyukasyk NS, Ileri M, Alper A, Senen K, Atak R, Hisar I, Yetkin E, Turhan H, Demirkan D. Increased blood coagulation and platelet activation in patients with infective endocarditis and embolic events. Clin Cardiol. 2004 Mar;27(3):154-8. doi: 10.1002/clc.4960270312.
- Background: PubMed 19597879Na S, Shim JK, Chun DH, Kim DH, Hong SW, Kwak YL. Stabilized infective endocarditis and altered heparin responsiveness during cardiopulmonary bypass. World J Surg. 2009 Sep;33(9):1862-7. doi: 10.1007/s00268-009-0107-2.
- Background: PubMed 22302637Thota R, Ganti AK, Subbiah S. Apparent heparin resistance in a patient with infective endocarditis secondary to elevated factor VIII levels. J Thromb Thrombolysis. 2012 Jul;34(1):132-4. doi: 10.1007/s11239-012-0692-z.
- Background: PubMed 28957943Yu S, Khalpey ZI, Wong RK, Huynh T, Nielsen VG. Complete antithrombin replacement for anticoagulation for cardiopulmonary bypass to repair severe infective mitral valve endocarditis. Blood Coagul Fibrinolysis. 2018 Jan;29(1):123-125. doi: 10.1097/MBC.0000000000000668.
- Background: PubMed 12633799Ileri M, Alper A, Senen K, Durmaz T, Atak R, Hisar I, Yetkin E, Turhan H, Demirkan D. Effect of infective endocarditis on blood coagulation and platelet activation and comparison of patients with to those without embolic events. Am J Cardiol. 2003 Mar 15;91(6):689-92. doi: 10.1016/s0002-9149(02)03405-7.
- Background: PubMed 18948034Salis S, Mazzanti VV, Merli G, Salvi L, Tedesco CC, Veglia F, Sisillo E. Cardiopulmonary bypass duration is an independent predictor of morbidity and mortality after cardiac surgery. J Cardiothorac Vasc Anesth. 2008 Dec;22(6):814-22. doi: 10.1053/j.jvca.2008.08.004. Epub 2008 Oct 22.
- Background: PubMed 29579243Salsano A, Giacobbe DR, Sportelli E, Olivieri GM, Natali R, Prevosto M, Del Bono V, Viscoli C, Santini F. Aortic cross-clamp time and cardiopulmonary bypass time: prognostic implications in patients operated on for infective endocarditis. Interact Cardiovasc Thorac Surg. 2018 Sep 1;27(3):328-335. doi: 10.1093/icvts/ivy085.
- Individual participant dataSharing planned: Undecided
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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.
Markus W Hollmann, MD,PhD,PhD principal investigator
Amsterdam Academic Medical Center
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 Endocarditis and Coagulation Disorder, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 4 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: looking for participants now, as of the sponsor's last update on 25 Jul 2023. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer S Breel, MPA,MSc (+31610019257, j.s.breel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic complications (time frame: up to 1 year). 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 NCT05139589, which also lists 14 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 25 Jul 2023.