Impact of Microparticles on Postoperative Complications in Surgical Patients - Full Text View

Purpose

Microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. The impact of surgical operations on quantity and quality of microparticles remains unknown. In this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.

Condition
Neoplasm, Hepatic Pancreatic Neoplasms Colorectal Neoplasms

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by University of Bern:

Primary Outcome Measures:

Postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Serum

Enrollment:	108
Study Start Date:	February 2008
Study Completion Date:	January 2010
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
F64 We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing cardiac or hepatobiliary or colorectal surgery. Setting: university hospital.

Criteria

Inclusion Criteria:

Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours

Exclusion Criteria:

Laparoscopic operations
emergency operations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677781

Locations

Switzerland
Department of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University of Bern

Investigators

Principal Investigator:

Guido Beldi, MD

Bern University Hospital

More Information

Publications:

Diamant M, Tushuizen ME, Sturk A, Nieuwland R. Cellular microparticles: new players in the field of vascular disease? Eur J Clin Invest. 2004 Jun;34(6):392-401. Review.

Piccin A, Murphy WG, Smith OP. Circulating microparticles: pathophysiology and clinical implications. Blood Rev. 2007 May;21(3):157-71. Epub 2006 Nov 22. Review.

Fujimi S, Ogura H, Tanaka H, Koh T, Hosotsubo H, Nakamori Y, Kuwagata Y, Shimazu T, Sugimoto H. Activated polymorphonuclear leukocytes enhance production of leukocyte microparticles with increased adhesion molecules in patients with sepsis. J Trauma. 2002 Mar;52(3):443-8.

Nieuwland R, Berckmans RJ, McGregor S, Böing AN, Romijn FP, Westendorp RG, Hack CE, Sturk A. Cellular origin and procoagulant properties of microparticles in meningococcal sepsis. Blood. 2000 Feb 1;95(3):930-5.

Ogura H, Kawasaki T, Tanaka H, Koh T, Tanaka R, Ozeki Y, Hosotsubo H, Kuwagata Y, Shimazu T, Sugimoto H. Activated platelets enhance microparticle formation and platelet-leukocyte interaction in severe trauma and sepsis. J Trauma. 2001 May;50(5):801-9.

Soriano AO, Jy W, Chirinos JA, Valdivia MA, Velasquez HS, Jimenez JJ, Horstman LL, Kett DH, Schein RM, Ahn YS. Levels of endothelial and platelet microparticles and their interactions with leukocytes negatively correlate with organ dysfunction and predict mortality in severe sepsis. Crit Care Med. 2005 Nov;33(11):2540-6.

Boulanger CM, Scoazec A, Ebrahimian T, Henry P, Mathieu E, Tedgui A, Mallat Z. Circulating microparticles from patients with myocardial infarction cause endothelial dysfunction. Circulation. 2001 Nov 27;104(22):2649-52.

Héloire F, Weill B, Weber S, Batteux F. Aggregates of endothelial microparticles and platelets circulate in peripheral blood. Variations during stable coronary disease and acute myocardial infarction. Thromb Res. 2003 Jun 1;110(4):173-80.

Morel O, Hugel B, Jesel L, Lanza F, Douchet MP, Zupan M, Chauvin M, Cazenave JP, Freyssinet JM, Toti F. Sustained elevated amounts of circulating procoagulant membrane microparticles and soluble GPV after acute myocardial infarction in diabetes mellitus. Thromb Haemost. 2004 Feb;91(2):345-53.

Morel O, Jesel L, Freyssinet JM, Toti F. Elevated levels of procoagulant microparticles in a patient with myocardial infarction, antiphospholipid antibodies and multifocal cardiac thrombosis. Thromb J. 2005 Oct 11;3:15.

van der Zee PM, Biró E, Ko Y, de Winter RJ, Hack CE, Sturk A, Nieuwland R. P-selectin- and CD63-exposing platelet microparticles reflect platelet activation in peripheral arterial disease and myocardial infarction. Clin Chem. 2006 Apr;52(4):657-64. Epub 2006 Jan 26.

Ardoin SP, Shanahan JC, Pisetsky DS. The role of microparticles in inflammation and thrombosis. Scand J Immunol. 2007 Aug-Sep;66(2-3):159-65. Review.

Andoh A, Tsujikawa T, Hata K, Araki Y, Kitoh K, Sasaki M, Yoshida T, Fujiyama Y. Elevated circulating platelet-derived microparticles in patients with active inflammatory bowel disease. Am J Gastroenterol. 2005 Sep;100(9):2042-8.

Chamouard, P., D. Desprez, B. Hugel, C. Kunzelmann, C. Gidon-Jeangirard, M. Lessard, R. Baumann, J.M. Freyssinet, and L. Grunebaum. 2005. Circulating cell-derived microparticles in Crohn's disease. Dig Dis Sci 50:574-580.

Jimenez JJ, Jy W, Mauro LM, Horstman LL, Soderland C, Ahn YS. Endothelial microparticles released in thrombotic thrombocytopenic purpura express von Willebrand factor and markers of endothelial activation. Br J Haematol. 2003 Dec;123(5):896-902.

Proulle V, Hugel B, Guillet B, Grunebaum L, Lambert T, Freyssinet JM, Dreyfus M. Circulating microparticles are elevated in haemophiliacs and non-haemophilic individuals aged <18 years. Br J Haematol. 2005 Nov;131(4):487-9.

Responsible Party:	Guido Beldi, MD, Department of visceral and transplant surgery, Inselspital Bern, Switzerland
ClinicalTrials.gov Identifier:	NCT00677781 History of Changes
Other Study ID Numbers:	KEK251_07
Study First Received:	May 8, 2008
Last Updated:	September 5, 2011
Health Authority:	Switzerland: Ethikkommission

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Pancreatic Neoplasms
Postoperative Complications
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013