Clinical Trial: Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Prospective, Randomized, Parallel-group Single Center Study to Evaluate the Use of Thromboelastometry (ROTEM) in Patients Undergoing Spine Surgeries

Brief Summary: The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood Products vs control cases without ROTEM assessment.

Detailed Summary:

Study methods This is a prospective, randomized parallel-group single center study in patients undergoing elective major spine surgery. Patients will be randomized to ROTEM-guided hemostatic therapy algorithm or standard of care hemostatic therapy: arterial blood gas analysis (ABG), normalized index ratio (INR), prothrombin time (PT), thromboplastin time (aPTT), hemoglobin (Hb), platelets, and fibrinogen.

Study Procedures Patients will be randomized in a 1:1 ratio to either standard of care coagulation tests (SOC) or ROTEM. No changes in surgery or anesthesia technique will be made for the purposes of the study.

Standard of Care Coagulation Tests If patients are randomized to standard of care coagulation tests, these will be performed according to Ohio State University Wexner Medical Center standard practices and attending's criteria.

Standard of care tests include but are not limited to: hemoglobin, platelet count, fibrinogen concentration, INR, aPTT, and PT. These will be performed at fixed time points (preoperatively, every 2 hours intraoperatively, procedure completion, and 24 hours after procedure completion). Arterial blood gases will be performed repetitively intraoperative at a fixed range every 1-hour or at attending's criteria, as well as any postoperative laboratory tests.

ROTEM If patients are randomized to ROTEM, the anesthesiologist will be blinded to any intraoperative conventional coagulation test that might be performed.

ROTEM will be used according to the manufacturer's instructions, using equipment and test reagents provided by Tem International GmbH. All tests will be performed at the bedside by a clinical perfusionist trained to perform ROTEM. A specific
Sponsor: Ohio State University

Current Primary Outcome: Intraoperative Autologue blood product transfusion. [ Time Frame: Within surgery ]

Red Blood Cells, Fresh Frozen Plasma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative blood product transfusion [ Time Frame: Within postoperative 24 hours ]
    Packed Red Blood Cells transfusion, and Fresh frozen plasma transfusion.
  • Cryoprecipitate Transfusion Requirements [ Time Frame: Within Surgery and Postoperative 24 hours ]
    Reported in ml
  • Platelet Transfusion Requirements [ Time Frame: Within Surgery and Postoperative 24 hours ]
    Reported in ml.
  • Fibrinogen concentrate Transfusion Requirements [ Time Frame: Within Surgery and Postoperative 24 hours ]
    Reported in ml
  • Prothrombin Complex transfusion Requirements [ Time Frame: Within Surgery and Postoperative 24 hours ]
    Reported in mL and Units.
  • Factor VII Transfusion Requirements [ Time Frame: Within Surgery and Postoperative 24 hours ]
    Reported in Units.
  • Need for mechanical Ventilation During Postoperative period [ Time Frame: Within 30 days after surgery ]
  • Length of Stay on intensive care unit (ICU) [ Time Frame: Within 30 days after surgery ]
  • Length of Stay on post anesthesia care unit (PACU) [ Time Frame: Within 30 days after surgery ]
  • Overall Hospital Stay [ Time Frame: Within 30 days after surgery ]
  • Postoperative Prothrombin Time Tests Results [ Time Frame: within 72 hours of postoperative period. ]
    Days 1 and 3 if available
  • Postoperative INR (Index Normalized Ratio) Tests Results [ Time Frame: within 72 hours of postoperative period. ]
    Days 1 and 3 if available
  • Postoperative PTT ( thromboplastin time) Tests Results [ Time Frame: within 72 hours of postoperative period. ]
    Days 1 and 3 if available
  • Overall Infection Rate [ Time Frame: within 30 days after surgery ]
  • Mortality [ Time Frame: within 30 days after surgery ]
    7 and 30 day mortality
  • Cardiovascular complications rate [ Time Frame: within Postoperative 30 days ]
  • Thromboembolic Complications rate [ Time Frame: within Postoperative 30 days ]
  • Respiratory Complications rate [ Time Frame: Within postoperative 30 days ]
  • Renal System Complications rate [ Time Frame: Within 30 postoperative days ]
  • Cerebrovascular complications rate [ Time Frame: within 30 postoperative days ]
  • Infectious complications rate [ Time Frame: Within postoperative 30 days ]
  • Reintervention related to postoperative bleeding rate [ Time Frame: Within postoperative 30 days ]


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: January 5, 2016
Date Started: November 2015
Date Completion: December 2017
Last Updated: January 30, 2017
Last Verified: April 2016