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

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ROTEM
Standard of Care
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Loss, Surgical focused on measuring ROTEM, Thromboelastometry, spine surgery, allogenic blood transfusion, blood loss, red blood cell transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ROTEM

    CONTROL/STANDARD OF CARE

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion
    Intraoperative Autologue Blood Product Transfusion

    Secondary Outcome Measures

    Postoperative Blood Product Transfusion
    Fresh frozen plasma transfusion.
    Number of Participants Requiring Cryoprecipitate Transfusion
    Number of participants
    Number of Participants Requiring Platelet Transfusion
    Number of participants
    Fibrinogen Concentrate Transfusion Requirements
    Percentage
    Prothrombin Complex Transfusion Requirements
    Percentage
    Factor VII Transfusion Requirements
    Percentage
    Need for Mechanical Ventilation During Postoperative Period
    Length of Stay on Intensive Care Unit (ICU)
    Length of Stay on Post Anesthesia Care Unit (PACU)
    Overall Hospital Stay
    Surgical Site Infection
    Mortality
    30 day mortality
    Cardiovascular Complications Rate
    Thromboembolic Complications Rate
    Respiratory Complications Rate
    Renal System Complications Rate
    Cerebrovascular Complications Rate
    Infectious Complications Rate
    Reintervention Related to Postoperative Bleeding Rate

    Full Information

    First Posted
    January 5, 2016
    Last Updated
    November 3, 2022
    Sponsor
    Ohio State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02740374
    Brief Title
    Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery
    Acronym
    ROTEM_SPINE
    Official Title
    A Prospective, Randomized, Parallel-group Single Center Study to Evaluate the Use of Thromboelastometry (ROTEM) in Patients Undergoing Spine Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    January 28, 2021 (Actual)
    Study Completion Date
    January 28, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss, Surgical
    Keywords
    ROTEM, Thromboelastometry, spine surgery, allogenic blood transfusion, blood loss, red blood cell transfusion

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ROTEM
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CONTROL/STANDARD OF CARE
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    ROTEM
    Intervention Description
    ROTEM coagulation assessment and guided transfusion management.
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard Coagulation Tests assessment and guided transfusion management
    Primary Outcome Measure Information:
    Title
    Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion
    Description
    Intraoperative Autologue Blood Product Transfusion
    Time Frame
    Within surgery
    Secondary Outcome Measure Information:
    Title
    Postoperative Blood Product Transfusion
    Description
    Fresh frozen plasma transfusion.
    Time Frame
    Within postoperative 24 hours
    Title
    Number of Participants Requiring Cryoprecipitate Transfusion
    Description
    Number of participants
    Time Frame
    Perioperative- up to 24 hours after surgery start time (cumulative)
    Title
    Number of Participants Requiring Platelet Transfusion
    Description
    Number of participants
    Time Frame
    Perioperative- up to 24 hours after surgery start time (cumulative)
    Title
    Fibrinogen Concentrate Transfusion Requirements
    Description
    Percentage
    Time Frame
    Within Surgery and Postoperative 24 hours
    Title
    Prothrombin Complex Transfusion Requirements
    Description
    Percentage
    Time Frame
    Within Surgery and Postoperative 24 hours
    Title
    Factor VII Transfusion Requirements
    Description
    Percentage
    Time Frame
    Within Surgery and Postoperative 24 hours
    Title
    Need for Mechanical Ventilation During Postoperative Period
    Time Frame
    Within 30 days after surgery
    Title
    Length of Stay on Intensive Care Unit (ICU)
    Time Frame
    Within 30 days after surgery
    Title
    Length of Stay on Post Anesthesia Care Unit (PACU)
    Time Frame
    Within 30 days after surgery
    Title
    Overall Hospital Stay
    Time Frame
    Within 30 days after surgery
    Title
    Surgical Site Infection
    Time Frame
    within 30 days after surgery
    Title
    Mortality
    Description
    30 day mortality
    Time Frame
    within 30 days after surgery
    Title
    Cardiovascular Complications Rate
    Time Frame
    within Postoperative 30 days
    Title
    Thromboembolic Complications Rate
    Time Frame
    within Postoperative 30 days
    Title
    Respiratory Complications Rate
    Time Frame
    Within postoperative 30 days
    Title
    Renal System Complications Rate
    Time Frame
    Within 30 postoperative days
    Title
    Cerebrovascular Complications Rate
    Time Frame
    within 30 postoperative days
    Title
    Infectious Complications Rate
    Time Frame
    Within postoperative 30 days
    Title
    Reintervention Related to Postoperative Bleeding Rate
    Time Frame
    Within postoperative 30 days
    Other Pre-specified Outcome Measures:
    Title
    Cost Comparison
    Description
    Compare costs of ROTEM guided therapy or Standard of Care guided therapy.
    Time Frame
    within 30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Galina Dimitrova, MD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery

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