Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery

NCT ID: NCT02740374

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-01-28

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.

Conditions

Blood Loss, Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ROTEM

Intervention Type: DEVICE

ROTEM coagulation assessment and guided transfusion management.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard Coagulation Tests assessment and guided transfusion management

Interventions

ROTEM

ROTEM coagulation assessment and guided transfusion management.

Intervention Type: DEVICE

Standard of Care

Standard Coagulation Tests assessment and guided transfusion management

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Galina Dimitrova

M.D, Principal INvestigator, Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Galina Dimitrova, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2014H0447

Identifier Type: -

Identifier Source: org_study_id