Impact of Microparticles on Postoperative Complications in Surgical Patients
Sponsor
University of Bern (Other)
Overall Status
Completed
CT.gov ID
NCT00677781
Collaborator
(none)
108
1
23
4.7
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
108 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| F64 We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study) |
Outcome Measures
Primary Outcome Measures
- Postoperative morbidity [30 days]
Secondary Outcome Measures
- Hospital stay [30 days]
- Mortality [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Chamouard P, Desprez D, Hugel B, Kunzelmann C, Gidon-Jeangirard C, Lessard M, Baumann R, Freyssinet JM, Grunebaum L. Circulating cell-derived microparticles in Crohn's disease. Dig Dis Sci. 2005 Mar;50(3):574-80.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00677781
Other Study ID Numbers:
- KEK251_07
First Posted:
May 15, 2008
Last Update Posted:
Sep 7, 2011
Last Verified:
Sep 1, 2011