Clinical trial NCT00839995: Use of ROTEM for Multi-level Spine Surgery
Official title: A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation
Keywords: To determine the efficacy of ROTEM on assessing coagulation profiles.
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Large metropolitan hospital.

Brief summary: The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective open spine (cervical, thoracic, and/or lumbar) surgery with anticipated blood loss of \> 1 L
* 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 pre-existing hemostatic abnormality
* 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

Primary outcomes:
measure: Coagulation profiles.
timeFrame: One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Hugh C Hemmings, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol. 2007 Jul-Aug;73(7-8):401-15. Epub 2007 Mar 27.
citation: 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.
citation: 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.
citation: Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.