Study Results
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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COMPLETED
41 participants
OBSERVATIONAL
2009-02-28
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients undergoing multi-level spine surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Age 18 to 100 years of age
* ASA physical status 1 to 3
* Arterial line indicated for the intraoperative management of the patient and in place prior to incision
* Informed consent obtained
Exclusion Criteria
* Known clopidogrel use within 10 days prior to surgery
* Known warfarin use within 5 days prior to surgery
* Known pregnancy
* Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
* Inclusion in another clinical research study
* An investigator of this study
* Subject's refusal or inability to agree to and sign the Informed Consent form in English
18 Years
80 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Hugh Hemmings
Vice Chair of Research
Principal Investigators
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Hugh C Hemmings, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical College
New York, New York, United States
Countries
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References
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Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. doi: 10.1056/NEJMra067742. No abstract available.
Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol. 2007 Jul-Aug;73(7-8):401-15. Epub 2007 Mar 27.
Ebinger T. Concerning Hanecke P, Klouche M: Thrombelastography Today: Practicability and Analytical Power. Transfus Med Hemother 2007;34:421-428. Transfus Med Hemother. 2008;35(4):324-326. doi: 10.1159/000143229. Epub 2008 Jul 21. No abstract available.
Hu SS. Blood loss in adult spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S3-5. doi: 10.1007/s00586-004-0753-x. Epub 2004 Jun 10.
Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
Yuan S, Ferrell C, Chandler WL. Comparing the prothrombin time INR versus the APTT to evaluate the coagulopathy of acute trauma. Thromb Res. 2007;120(1):29-37. doi: 10.1016/j.thromres.2006.07.002. Epub 2006 Aug 2.
Ciavarella D, Reed RL, Counts RB, Baron L, Pavlin E, Heimbach DM, Carrico CJ. Clotting factor levels and the risk of diffuse microvascular bleeding in the massively transfused patient. Br J Haematol. 1987 Nov;67(3):365-8. doi: 10.1111/j.1365-2141.1987.tb02359.x.
Segal JB, Dzik WH; Transfusion Medicine/Hemostasis Clinical Trials Network. Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review. Transfusion. 2005 Sep;45(9):1413-25. doi: 10.1111/j.1537-2995.2005.00546.x.
Ganter MT, Hofer CK. Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg. 2008 May;106(5):1366-75. doi: 10.1213/ane.0b013e318168b367.
American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology. 2006 Jul;105(1):198-208. doi: 10.1097/00000542-200607000-00030. No abstract available.
Spalding GJ, Hartrumpf M, Sierig T, Oesberg N, Kirschke CG, Albes JM. Cost reduction of perioperative coagulation management in cardiac surgery: value of "bedside" thrombelastography (ROTEM). Eur J Cardiothorac Surg. 2007 Jun;31(6):1052-7. doi: 10.1016/j.ejcts.2007.02.022. Epub 2007 Mar 29.
Other Identifiers
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0811010079
Identifier Type: -
Identifier Source: org_study_id
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