Use of ROTEM for Multi-level Spine Surgery

NCT00839995 | Completed

• 1 other identifier: 0811010079
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation

Keywords

To determine the efficacy of ROTEM on assessing coagulation profiles.

Outcome Measures

Primary Outcomes (1)

• Coagulation profiles.

  One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.

Study Arms (1)

Patients undergoing multi-level spine surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Large metropolitan hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.
• An investigator of this study
• Subject's refusal or inability to agree to and sign the Informed Consent form in English

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (11)

• 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.

  PMID: 17538089 BACKGROUND

• Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol. 2007 Jul-Aug;73(7-8):401-15. Epub 2007 Mar 27.

  PMID: 17380100 BACKGROUND

• 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.

  PMID: 21512650 BACKGROUND

• 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.

  PMID: 15197630 BACKGROUND

• Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.

  PMID: 15784122 BACKGROUND

• 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.

  PMID: 16887171 BACKGROUND

• 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.

  PMID: 3689699 BACKGROUND

• 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.

  PMID: 16131373 BACKGROUND

• 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.

  PMID: 18420846 BACKGROUND

• 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.

  PMID: 16810012 BACKGROUND

• 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.

  PMID: 17398108 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

a small sample of blood will be obtained from a pre-existing arterial line.

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hugh C Hemmings, M.D., Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: March 5, 2012

Record last verified: 2012-02

Locations

US (1)