The ENDOCARDITIS AUMC Data Collection

NCT05139589 | Recruiting

• 1 other identifier: W21_466#21.518
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endocarditis; Coagulation Disorder; Valve Disease, Heart

Outcome Measures

Primary Outcomes (1)

• Thromboembolic complications

  Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)

  up to 1 year

Secondary Outcomes (2)

• Incidence of perioperative coagulation abnormalities

  First 24 hours after surgery

• Differences in incidence of pathogens and the relation with disease severity

  Up to 30 days

Study Arms (3)

Infective endocarditis, surgical arm

Patients with infective endocardits requiring valve surgery

Other: None, observational

Infective endocarditis, conservative arm

Patients with infective endocardits, not requiring valve surgery

Other: None, observational

Valve disease, heart, surgically repaired

Patients requiring valve surgery

Other: None, observational

Interventions

None, observational 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; Infective endocarditis, surgical arm; Valve disease, heart, surgically repaired

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• Previous history of coagulation disorders

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (14)

• 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.

  PMID: 19273776 BACKGROUND

• 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.

  PMID: 25975469 BACKGROUND

• 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.

  PMID: 26341945 BACKGROUND

• 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.

  PMID: 25230604 BACKGROUND

• 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.

  PMID: 20212293 BACKGROUND

• 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.

  PMID: 15049384 BACKGROUND

• 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.

  PMID: 19597879 BACKGROUND

• 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.

  PMID: 22302637 BACKGROUND

• 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.

  PMID: 28957943 BACKGROUND

• 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.

  PMID: 12633799 BACKGROUND

• 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.

  PMID: 18948034 BACKGROUND

• 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.

  PMID: 29579243 BACKGROUND

• 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.

  PMID: 26750645 BACKGROUND

• 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.

  PMID: 27363652 BACKGROUND

MeSH Terms

Conditions

Endocarditis; Hemostatic Disorders; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Markus W Hollmann, MD,PhD,PhD

  Amsterdam Academic Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer S Breel, MPA,MSc

CONTACT

+31610019257; j.s.breel@amsterdamumc.nl

Henning Hermanns, MD,PhD

CONTACT

+31205669111; h.hermanns@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 1, 2021
• Study Start: August 6, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

NL (1)