Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery (ROTEM_SPINE)

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Device: ROTEM; Other: Standard of Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female age 18 years or older.
2. Able to provide inform consent or have a legal authorized representative able to sign consent on the patients behalf.
3. 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.

4. Patients schedule to undergo elective neurosurgery, orthopedic, or combined procedures that are expected to receive blood products intraoperatively.

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Exclusion Criteria:

1. Subjects younger than 18 years old.
2. Subjects who are prisoners.
3. Subjects who refuse transfusion of blood products.
4. Females who are pregnant or breastfeeding.
5. Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ROTEM; 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; ROTEM coagulation assessment and guided transfusion management.
Active Comparator: CONTROL/STANDARD OF CARE; 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; Standard Coagulation Tests assessment and guided transfusion management

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Comparison	Compare costs of ROTEM guided therapy or Standard of Care guided therapy.	within 30 days after surgery

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Galina Dimitrova, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: blood loss; ROTEM; spine surgery; Thromboelastometry; red blood cell transfusion; allogenic blood transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: 2014H0447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No