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

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

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.

Study Overview

• Status: Terminated
• Conditions: Spine Surgery; Rotational Thrombo-elastometry (ROTEM)
• Intervention / Treatment: Device: ROTEM-based coagulation monitoring; Procedure: Spine surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 18 and < 80 years old.
2. Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
3. Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
4. Preoperative hemoglobin Level >10 g/dl.
5. OR time > 4 hours.
6. No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).

Exclusion Criteria:

1. Age < 18 or age > 80 years old.
2. Anterior spine surgeries or posterior spine surgeries involving <5 levels.
3. Minimally invasive spine surgeries.
4. Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
5. Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values.
6. Trauma and Emergency spine surgeries.
7. Patients with spine malignancy diagnosis, either primary or metastatic.
8. OR time < 4 hours.
9. Patients who refuse to use allogenic blood products.
10. Patients with contraindications for the use of anti-fibrinolytic therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sergio Mendoza-Lattes, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): May 16, 2018

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Pro00070817