Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery

Study Overview
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Brief Summary
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The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.

Detailed Description
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The aim of the study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on reducing total blood product use during complex spine surgery. The primary outcome will include estimated blood losses and blood product utilization during and after surgery (48 hours). Secondary outcomes also include hospital length of stay, and cost analysis of the 2 methodologies.

Official Title
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Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study

Conditions
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Spine Surgery, Rotational Thrombo-elastometry (ROTEM)

Intervention / Treatment
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* Device: ROTEM-based coagulation monitoring
* Procedure: Spine surgery


Participation Criteria
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Eligibility Criteria
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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 (Tranexamic 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROTEM Group<br>Patients who are randomized to receive ROTEM | Device: ROTEM-based coagulation monitoring<br> <br> Procedure: Spine surgery<br> <br> |
| Other: Control Group<br>Patients who are randomized not to receive ROTEM | Procedure: Spine surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss (mL) |  | during surgery (up to approximately 10 hours) | 
| Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused |  | up to 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay After Surgery |  | typically 5-7 days | 
| Cost Analysis, as Measured by Total Dollar Value of Blood Products Used |  | during surgery (up to approximately 10 hours) | 
| Amount of Recovered Blood Transfused During the Procedure (mL) |  | during surgery (up to approximately 10 hours) | 
| Drain Output (mL) |  | first 24 hours after surgery | 
| Amount of Blood Products Transfused, Measured in Units |  | during surgery (up to approximately 10 hours) | 
| Amount of Blood Products Transfused, Measured in Units |  | 48 hours following surgery | 
| Change in Hemoglobin (g/dL) | Reporting the change in hemoglobin from baseline to approximately 10 hours. | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | 
| Change in Platelet Count | Reporting the change in platelet count from baseline to approximately 10 hours. | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | 
| Change in Prothrombin Time |  | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | 
| Change in International Normalized Ratio (PT/INR) |  | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | 
| Change in Activated Partial Thromboplastin Time (aPTT) |  | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | 
| Change in Fibrinogen (g/L) |  | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) |