Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery

Study Overview
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Brief Summary
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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 Description
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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 algorithm has been created and should be followed according to clinical criteria ROTEM monitoring will be performed in patients with signs of clinically relevant diffuse bleeding and in whom blood transfusion is considered (Temp >35 Celsius degrees; pH lower than 7.2; Cai above 4.6 mg/dL; Hb below 9g/dL, or below 10g/dL with anticipated greater blood loss) or at a fixed range every 2 hours or at Anesthesiologist criteria based on patient's clinical situation. Patient´s clinical situation should be consider as the most important component on the transfusion decision-making process. Packed erythrocytes will be transfused to maintain hemoglobin concentrations higher 9g/dl and higher 10g/dl in individuals with underlying cardiovascular disease or anticipated greater blood loss. Individual based dynamics strongly indicating the need for erythrocyte transfusion at anesthesiologist criteria will be also part of the transfusion making decision-making process (tachycardia, hypotension, sings of ischemia on electrocardiogram, lactic acidosis, and dynamics of bleeding). Assessment and reporting of Adverse Events The occurrence of adverse events (AE) and serious adverse events (SAE) will be recorded from the time of consent until discharge. For each AE, the relationship to the study procedures and monitoring, severity, expectedness, outcome will be determined by the PI and recorded in the study source accordingly If the case a subject withdraws from the study due to a serious adverse event the local Institutional Review Board (IRB) will be notified within 10 days.

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

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Device: ROTEM
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18 years or older. Able to provide inform consent or have a legal authorized representative able to sign consent on the patients behalf. Female subject with a negative urine or serum pregnancy test, or not of childbearing potential, defined as surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or are postmenopausal for at least 1 year. Patients schedule to undergo elective neurosurgery, orthopedic, or combined procedures that are expected to receive blood products intraoperatively. - Exclusion Criteria: Subjects younger than 18 years old. Subjects who are prisoners. Subjects who refuse transfusion of blood products. Females who are pregnant or breastfeeding. Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROTEM<br>ROTEM will be performed in patients with signs of clinically relevant bleeding and in whom blood transfusion is considered (Temp above 35 Celsius degrees; pH below 7.2; Cai above 4.6 mg/dL; Hb below 9g/dL, or below 10g/dL with anticipated greater blood loss) or at a fixed range every 2 hours or at Anesthesiologist criteria based on patient's clinical situation. There will be also be performed standard of care test for this set of patients, as described for the CONTROL arm. ROTEM results will guide transfusion strategy. | Device: ROTEM<br>* ROTEM coagulation assessment and guided transfusion management.<br>|
| Active Comparator: CONTROL/STANDARD OF CARE<br>If patients are randomized to standard coagulation tests (SCT), these will be performed according to Ohio State Wexner University Medical Center standard practices and attending's criteria, or at 2 hour intervals per protocol. 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 intraoperatively at a fixed range every 1-hour or at attending's criteria, as well as any postoperative laboratory tests. SCT will guide transfusion management. | Other: Standard of Care<br>* Standard Coagulation Tests assessment and guided transfusion management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion | Intraoperative Autologue Blood Product Transfusion | Within surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Blood Product Transfusion | Fresh frozen plasma transfusion. | Within postoperative 24 hours | 
| Number of Participants Requiring Cryoprecipitate Transfusion | Number of participants | Perioperative- up to 24 hours after surgery start time (cumulative) | 
| Number of Participants Requiring Platelet Transfusion | Number of participants | Perioperative- up to 24 hours after surgery start time (cumulative) | 
| Fibrinogen Concentrate Transfusion Requirements | Percentage | Within Surgery and Postoperative 24 hours | 
| Prothrombin Complex Transfusion Requirements | Percentage | Within Surgery and Postoperative 24 hours | 
| Factor VII Transfusion Requirements | Percentage | Within Surgery and Postoperative 24 hours | 
| Need for Mechanical Ventilation During Postoperative Period |  | Within 30 days after surgery | 
| Length of Stay on Intensive Care Unit (ICU) |  | Within 30 days after surgery | 
| Length of Stay on Post Anesthesia Care Unit (PACU) |  | Within 30 days after surgery | 
| Overall Hospital Stay |  | Within 30 days after surgery | 
| Surgical Site Infection |  | within 30 days after surgery | 
| Mortality | 30 day mortality | within 30 days after surgery | 
| Cardiovascular Complications Rate |  | within Postoperative 30 days | 
| Thromboembolic Complications Rate |  | within Postoperative 30 days | 
| Respiratory Complications Rate |  | Within postoperative 30 days | 
| Renal System Complications Rate |  | Within 30 postoperative days | 
| Cerebrovascular Complications Rate |  | within 30 postoperative days | 
| Infectious Complications Rate |  | Within postoperative 30 days | 
| Reintervention Related to Postoperative Bleeding Rate |  | Within postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROTEM, Thromboelastometry, spine surgery, allogenic blood transfusion, blood loss, red blood cell transfusion