A Prospective, Randomized, Parallel-group Single Center Study to Evaluate the Use of Thromboelastometry (ROTEM) in Patients Undergoing Spine Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ROTEM (Device)
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.
干预措施: Standard of Care (Other)
结局指标
主要结局
Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion
时间窗: Within surgery
Intraoperative Autologue Blood Product Transfusion
次要结局
- Reintervention Related to Postoperative Bleeding Rate(Within postoperative 30 days)
- Number of Participants Requiring Platelet Transfusion(Perioperative- up to 24 hours after surgery start time (cumulative))
- Fibrinogen Concentrate Transfusion Requirements(Within Surgery and Postoperative 24 hours)
- Prothrombin Complex Transfusion Requirements(Within Surgery and Postoperative 24 hours)
- Factor VII Transfusion Requirements(Within Surgery and Postoperative 24 hours)
- Need for Mechanical Ventilation During Postoperative Period(Within 30 days after surgery)
- Postoperative Blood Product Transfusion(Within postoperative 24 hours)
- Number of Participants Requiring Cryoprecipitate Transfusion(Perioperative- up to 24 hours after surgery start time (cumulative))
- Cerebrovascular Complications Rate(within 30 postoperative days)
- Infectious Complications Rate(Within postoperative 30 days)
- 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(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)
研究者
Galina Dimitrova
M.D, Principal INvestigator, Clinical Associate Professor
Ohio State University