Use of ROTEM for Multi-level Spine Surgery

Coagulation Clinical Trial

— ROTEM  

Official title:

A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839995
• Other study ID #: 0811010079
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: March 2, 2012
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coagulation

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View Citation

Ebinger T. Concerning Hänecke P, Klouche M: Thrombelastography Today: Practicability and Analytical Power. Transfus Med Hemother 2007;34:421-428. Transfus Med Hemother. 2008;35(4):324-326. Epub 2008 Jul 21. — View 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. Review. — View Citation

Hu SS. Blood loss in adult spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1:S3-5. Epub 2004 Jun 10. Review. — View Citation

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

Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. Review. — View Citation

Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. Review. — View 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. Review. — View 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. Epub 2007 Mar 29. — View 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. Epub 2006 Aug 2. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coagulation profiles.		One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.	Yes