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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROTEM | Experimental | 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. |
|
| CONTROL/STANDARD OF CARE | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROTEM | Device | ROTEM coagulation assessment and guided transfusion management. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion | Intraoperative Autologue Blood Product Transfusion | Within surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Comparison | Compare costs of ROTEM guided therapy or Standard of Care guided therapy. | within 30 days after surgery |
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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galina Dimitrova, MD | Ohio State University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. ROTEM: ROTEM coagulation assessment and guided transfusion management. |
| FG001 | 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. Standard of Care: Standard Coagulation Tests assessment and guided transfusion management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. ROTEM: ROTEM coagulation assessment and guided transfusion management. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion | Intraoperative Autologue Blood Product Transfusion | Red blood cell | Posted | Count of Participants | Participants | Within surgery |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. ROTEM: ROTEM coagulation assessment and guided transfusion management. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Uribe | The Ohio State University Wexner Medical Center - Department of Anesthesiology | 6142933559 | alberto.uribe@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2015 | Aug 5, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2018 | Aug 5, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care |
| Other |
Standard Coagulation Tests assessment and guided transfusion management |
|
| 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 |
| BG001 | 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. Standard of Care: Standard Coagulation Tests assessment and guided transfusion management |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. Standard of Care: Standard Coagulation Tests assessment and guided transfusion management |
|
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| Secondary | Postoperative Blood Product Transfusion | Fresh frozen plasma transfusion. | Fresh frozen plasma transfusion. | Posted | Count of Participants | Participants | Within postoperative 24 hours |
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|
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| Secondary | Number of Participants Requiring Cryoprecipitate Transfusion | Number of participants | Cryoprecipitate Transfusion Requirements | Posted | Count of Participants | Participants | Perioperative- up to 24 hours after surgery start time (cumulative) |
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| Secondary | Number of Participants Requiring Platelet Transfusion | Number of participants | Platelet Transfusion Requirements | Posted | Count of Participants | Participants | Perioperative- up to 24 hours after surgery start time (cumulative) |
|
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| Secondary | Fibrinogen Concentrate Transfusion Requirements | Percentage | Fibrinogen concentrate Transfusion Requirements | Posted | Count of Participants | Participants | Within Surgery and Postoperative 24 hours |
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| Secondary | Prothrombin Complex Transfusion Requirements | Percentage | Prothrombin Complex transfusion Requirements | Posted | Count of Participants | Participants | Within Surgery and Postoperative 24 hours |
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| Secondary | Factor VII Transfusion Requirements | Percentage | Factor VII Transfusion Requirements | Posted | Count of Participants | Participants | Within Surgery and Postoperative 24 hours |
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| Secondary | Need for Mechanical Ventilation During Postoperative Period | Need for mechanical Ventilation During Postoperative period | Posted | Count of Participants | Participants | Within 30 days after surgery |
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| Secondary | Length of Stay on Intensive Care Unit (ICU) | Posted | Mean | Standard Deviation | minutes | Within 30 days after surgery |
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| Secondary | Length of Stay on Post Anesthesia Care Unit (PACU) | Posted | Mean | Standard Deviation | minutes | Within 30 days after surgery |
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| Secondary | Overall Hospital Stay | Posted | Mean | Standard Deviation | minutes | Within 30 days after surgery |
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| Secondary | Surgical Site Infection | Posted | Count of Participants | Participants | within 30 days after surgery |
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| Secondary | Mortality | 30 day mortality | Posted | Count of Participants | Participants | within 30 days after surgery |
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| Secondary | Cardiovascular Complications Rate | Posted | Count of Participants | Participants | within Postoperative 30 days |
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| Secondary | Thromboembolic Complications Rate | Thromboembolic Complications rate | Posted | Count of Participants | Participants | within Postoperative 30 days |
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| Secondary | Respiratory Complications Rate | Posted | Count of Participants | Participants | Within postoperative 30 days |
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| Secondary | Renal System Complications Rate | Posted | Count of Participants | Participants | Within 30 postoperative days |
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| Secondary | Cerebrovascular Complications Rate | Posted | Count of Participants | Participants | within 30 postoperative days |
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| Secondary | Infectious Complications Rate | Posted | Count of Participants | Participants | Within postoperative 30 days |
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| Secondary | Reintervention Related to Postoperative Bleeding Rate | Posted | Count of Participants | Participants | Within postoperative 30 days |
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| Other Pre-specified | Cost Comparison | Compare costs of ROTEM guided therapy or Standard of Care guided therapy. | Not Posted | within 30 days after surgery | Participants |
| 1 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | 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. Standard of Care: Standard Coagulation Tests assessment and guided transfusion management | 1 | 57 | 0 | 57 | 0 | 57 |
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