Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study
Phase: NA
Conditions: Spine Surgery, Rotational Thrombo-elastometry (ROTEM)
Sponsor: Duke University

 
 
 
 
 
 
 
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During 
Complex Spine Surgery. A prospective randomized study. 
 
NCT02758184 
 
Document Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The Purpose of this study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation 
surveillance on reducing total blood product use during complex spine surgeries. 
 
Background & Significance 
 
Blood loss is one of the major challenges in complex spine surgeries. Previous reports suggests that 
multilevel spine surgery is associated with high risk of excessive bleeding (16%), and that 24% of patients 
undergoing a three-column osteotomy suffer massive blood losses (>4 L). Current measures to address 
this problem include the use of anti-fibrinolytic agents, Cell Saver® and hypotensive anesthesia. In spite 
of these measures, the use of blood products continues to be very high. Rotational thrombo-
elastometry (ROTEM) has been proven to be effective in reducing blood loss during liver transplant, 
cardiothoracic surgery and major trauma surgery. However, its application in major spine surgery has 
not become widespread. Spinal deformity surgery includes large incisions and extensive dissections, as 
well as major bleeding from epidural plexus and from highly vascularized cancellous vertebral bone. This 
study will evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on 
reducing total blood product use during complex spine surgeries by comparing with standard-of-care 
coagulation profile. 
 
Design & Procedures 
 
Major blood loss is one of the most common complications during complex spine surgery cases. This 
study will evaluate the effectiveness of intra-operative ROTEM-based coagulation surveillance on 
reducing total blood product use during complex spine surgeries by comparing with standard-of-care 
coagulation surveillance. The patients will be randomized to the ROTEM coagulation monitoring (+ROT) 
or to conventional coagulation monitoring (-ROT) groups. 
  
Primary Outcome: 
• 
The total number of units of PRBC transfused during surgery and during the following 48-hour 
hospital phase of care. 
• 
Estimated blood losses (EBL) during the procedure. 
  
Predictor variables: 
• 
Patients’ demographics: including age, sex, smoking history, medical comorbidities, 
preoperative diagnosis, procedure performed, OR duration, number of levels fused during the 
procedure, type and number of spine osteotomies during the procedure, the number of levels of 
decompression, the number of inter-body fusions. 
• 
Baseline laboratory values of the following: PT/INR, aPTT, platelet count, hemoglobin level. 
  
Secondary outcomes: 
• 
The use of Cell Saver® and the amount of recovered blood transfused during the procedure. 
• 
Drain output during the first 24 hours after surgery. 

• 
The amount and type of blood products (PRBC, FFP, Cryoprecipitate, Platelets) transfused during 
surgery, and during the 48 hours following surgery. 
• 
Laboratory values including hemoglobin, platelets count, PT/INR, aPTT, fibrinogen. 
• 
Serious adverse events during the hospital phase of care. 
• 
Cost analysis of ROTEM samples vs. Blood products. 
 
Selection of Subjects 
  
The subjects will be recruited from the operating room list at Duke University hospital, Durham, NC. 
Only patients who agree and consent to the study will be included. 
 
Subject Recruitment and Compensation 
 
Inclusion Criteria: 
• 
Age > 18 and < 80 years old. 
• 
Elective spine surgery cases, with a traditional open posterior approach and involving fusion of 
at least 5 levels. 
• 
Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative 
evaluation. 
• 
Preoperative hemoglobin Level >10 g/dl. 
• 
OR time > 4 hours. 
• 
No contraindication for the use of anti-fibrinolytic therapy (Tranaxemic acid). 
  
Exclusion Criteria: 
• 
Age < 18 or age > 80 years old. 
• 
Anterior spine surgeries or posterior spine surgeries involving <5 levels. 
• 
Minimally invasive spine surgeries. 
• 
Patients with known coagulopathies or bleeding tendencies or patients with abnormal 
coagulation laboratory values at baseline. 
• 
Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values. 
• 
Trauma and Emergency spine surgeries. 
• 
Patients with spine malignancy diagnosis, either primary or metastatic. 
• 
OR time < 4 hours. 
• 
Patients who refuse to use allogenic blood products. 
• 
Patients with contraindications for the use of anti-fibrinolytic therapy. 
  
Randomization: 
The patients will be randomized to the ROTEM coagulation monitoring (+ROT) or to conventional 
coagulation monitoring (-ROT) groups. A sealed envelope randomization will be performed in a 1:1 ratio. 
The research team members will not be blinded for the randomization results. 
  
There will be no subject compensation for participation in this study. 
 

Study Interventions 
 
Patients undergoing major spine surgery will be assigned to either ROTEM coagulation surveillance 
(+ROT) or to conventional coagulation surveillance (-ROT) groups. The main outcomes will be the 
estimated blood loss during the procedure and the amount of units of PRBCs transfused during the 
procedure and within the first 48 hours after the procedure. 
 
Risk/Benefit Assessment 
 
ROTEM is a test based on a blood-draw. Blood will be drawn for standard-of-care coagulation testing 
during the surgery from IV’s placed prior to or at the beginning of the procedure. The ROTEM will 
require a small additional sample of peripheral blood (<5mL). The anesthesiologist treating patients in 
the ROTEM arm of the trial will have this additional information to help guide blood product use during 
surgery. 
 
Data Analysis & Statistical Considerations 
 
Power analysis: 
Sample size was calculated with G-Power v.3.1.9.2 software. Considering that the average use of 5 units 
PRBCs for complex spine cases is reduced by 1 unit of PRBCs for each case, a sample size of 20 will 
provide a power P=0.978 with an α=0.007. 
  
Randomization: 
A randomization schedule will be generated with the online application www.randomization.com. 
  
Data Analysis: 
The t-test will be used to estimate the differences between two independent means for both 
coagulation surveillance groups (+ROT) and (-ROT).