Neoplasm, HepaticNCT00677781
Impact of Microparticles on Postoperative Complications in Surgical Patients
An observational study of Neoplasm, Hepatic and Pancreatic Neoplasms, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Hepatic, Pancreatic Neoplasms, Colorectal Neoplasms
- How many people
- 108 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients undergoing cardiac or hepatobiliary or colorectal surgery. Setting: university hospital.
Who may be able to join
- Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours
Who cannot join
- Laparoscopic operations
- emergency operations
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of visceral and transplant surgery, Bern University Hospital
Bern, 3010
About this study
Official title: The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery
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.
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| F64 | We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Measured: 30 days
Secondary outcomes (2)
Hospital stay
Measured: 30 days
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, HepaticStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Guido Beldi, MD, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677781
- Sponsor's protocol ID
- KEK251_07
- Status last verified
- Sep 2011
- First submitted
- 8 May 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1111/j.1365-2362.2004.01355.x.
PubMed 15200490Piccin A, Murphy WG, Smith OP. Circulating microparticles: pathophysiology and clinical implications. Blood Rev. 2007 May;21(3):157-71. doi: 10.1016/j.blre.2006.09.001. Epub 2006 Nov 22.
PubMed 17118501Fujimi 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. doi: 10.1097/00005373-200203000-00005.
PubMed 11901317Nieuwland R, Berckmans RJ, McGregor S, Boing 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.
PubMed 10648405Ogura 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. doi: 10.1097/00005373-200105000-00005.
PubMed 11371835Soriano 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. doi: 10.1097/01.ccm.0000186414.86162.03.
PubMed 16276178Boulanger 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. doi: 10.1161/hc4701.100516.
PubMed 11723013Heloire 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. doi: 10.1016/s0049-3848(03)00297-4.
PubMed 14512078Morel 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. doi: 10.1160/TH03-05-0294.
PubMed 14961163Morel 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. doi: 10.1186/1477-9560-3-15.
PubMed 16219103van der Zee PM, Biro 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. doi: 10.1373/clinchem.2005.057414. Epub 2006 Jan 26.
PubMed 16439610Ardoin SP, Shanahan JC, Pisetsky DS. The role of microparticles in inflammation and thrombosis. Scand J Immunol. 2007 Aug-Sep;66(2-3):159-65. doi: 10.1111/j.1365-3083.2007.01984.x.
PubMed 17635793Andoh 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. doi: 10.1111/j.1572-0241.2005.50381.x.
PubMed 16128950Chamouard 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. doi: 10.1007/s10620-005-2477-0.
PubMed 15810645Jimenez 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. doi: 10.1046/j.1365-2141.2003.04716.x.
PubMed 14632781
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00677781
- Acronym / sponsor ID
- KEK251_07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 May 2008 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F64 | – | –We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac or hepatobiliary or colorectal surgery. Setting: university hospital.
Key inclusion criteria (1 listed)
- Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours
Key exclusion criteria (2 listed)
- Laparoscopic operations
- emergency operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative morbidity
Time frame: 30 days
2 secondary outcomes
Hospital stay
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Background: PubMed 15200490Diamant 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. doi: 10.1111/j.1365-2362.2004.01355.x.
- Background: PubMed 17118501Piccin A, Murphy WG, Smith OP. Circulating microparticles: pathophysiology and clinical implications. Blood Rev. 2007 May;21(3):157-71. doi: 10.1016/j.blre.2006.09.001. Epub 2006 Nov 22.
- Background: PubMed 11901317Fujimi 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. doi: 10.1097/00005373-200203000-00005.
- Background: PubMed 10648405Nieuwland R, Berckmans RJ, McGregor S, Boing 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.
- Background: PubMed 11371835Ogura 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. doi: 10.1097/00005373-200105000-00005.
- Background: PubMed 16276178Soriano 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. doi: 10.1097/01.ccm.0000186414.86162.03.
- Background: PubMed 11723013Boulanger 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. doi: 10.1161/hc4701.100516.
- Background: PubMed 14512078Heloire 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. doi: 10.1016/s0049-3848(03)00297-4.
- Background: PubMed 14961163Morel 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. doi: 10.1160/TH03-05-0294.
- Background: PubMed 16219103Morel 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. doi: 10.1186/1477-9560-3-15.
- Background: PubMed 16439610van der Zee PM, Biro 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. doi: 10.1373/clinchem.2005.057414. Epub 2006 Jan 26.
- Background: PubMed 17635793Ardoin SP, Shanahan JC, Pisetsky DS. The role of microparticles in inflammation and thrombosis. Scand J Immunol. 2007 Aug-Sep;66(2-3):159-65. doi: 10.1111/j.1365-3083.2007.01984.x.
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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. This study is not recruiting at the moment.
Guido Beldi, MD principal investigator
Bern University Hospital
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 Neoplasm, Hepatic and Pancreatic Neoplasms, run by University of Bern at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 Sep 2011. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morbidity (time frame: 30 days). 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 NCT00677781, which also lists 16 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 7 Sep 2011.