Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery (ROTEM_SPINE)
Blood Loss, Surgical
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
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ROTEM
CONTROL/STANDARD OF CARE
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.