The ENDOCARDITIS AUMC Data Collection

NCT ID: NCT05139589

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-06

Study Completion Date

2030-12-31

Brief Summary

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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

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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

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Endocarditis Coagulation Disorder Valve Disease, Heart

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Infective endocarditis, surgical arm

Patients with infective endocardits requiring valve surgery

None, observational

Intervention Type OTHER

Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery

Infective endocarditis, conservative arm

Patients with infective endocardits, not requiring valve surgery

None, observational

Intervention Type OTHER

Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery

Valve disease, heart, surgically repaired

Patients requiring valve surgery

None, observational

Intervention Type OTHER

Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery

Interventions

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None, observational

Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Previous history of coagulation disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Breel

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus W Hollmann, MD,PhD,PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam Academic Medical Center

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Jennifer S Breel, MPA,MSc

Role: CONTACT

+31610019257

Henning Hermanns, MD,PhD

Role: CONTACT

+31205669111 ext. 62533

Facility Contacts

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Jennifer S Breel, MPA,MSc.

Role: primary

+316 1001 9257

Henning Hermanns, MD, PhD

Role: backup

+31205669111 ext. 62533

References

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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.

Reference Type BACKGROUND
PMID: 19273776 (View on PubMed)

Pant 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.

Reference Type BACKGROUND
PMID: 25975469 (View on PubMed)

Cahill 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.

Reference Type BACKGROUND
PMID: 26341945 (View on PubMed)

Durante-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.

Reference Type BACKGROUND
PMID: 25230604 (View on PubMed)

Prendergast 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.

Reference Type BACKGROUND
PMID: 20212293 (View on PubMed)

Buyukasyk 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.

Reference Type BACKGROUND
PMID: 15049384 (View on PubMed)

Na 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.

Reference Type BACKGROUND
PMID: 19597879 (View on PubMed)

Thota 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.

Reference Type BACKGROUND
PMID: 22302637 (View on PubMed)

Yu 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.

Reference Type BACKGROUND
PMID: 28957943 (View on PubMed)

Ileri 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.

Reference Type BACKGROUND
PMID: 12633799 (View on PubMed)

Salis 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.

Reference Type BACKGROUND
PMID: 18948034 (View on PubMed)

Salsano 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.

Reference Type BACKGROUND
PMID: 29579243 (View on PubMed)

Dahn 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.

Reference Type BACKGROUND
PMID: 26750645 (View on PubMed)

Deppe 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.

Reference Type BACKGROUND
PMID: 27363652 (View on PubMed)

Other Identifiers

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W21_466#21.518

Identifier Type: -

Identifier Source: org_study_id

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