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

Not Applicable

Terminated

• Conditions: Rotational Thrombo-elastometry (ROTEM); Spine Surgery
• Interventions: Procedure: Spine surgery; Device: ROTEM-based coagulation monitoring

• Registration Number: NCT02758184
• Lead Sponsor: Duke University

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Start: 2016-06
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Disposition First Submitted: 2021-03-16
• Disposition First Submitted QC: 2021-03-16
• Disposition First Posted: 2021-03-19
• Status Verified: 2022-03
• Results First Submitted: 2022-03-31
• Results First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Results First Posted: 2022-04-27
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Spine surgery	Patients who are randomized not to receive ROTEM
ROTEM Group	ROTEM-based coagulation monitoring	Patients who are randomized to receive ROTEM
ROTEM Group	Spine surgery	Patients who are randomized to receive ROTEM

Primary Outcome Measures

Name	Time	Method
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused	up to 48 hours after surgery
Estimated Blood Loss (mL)	during surgery (up to approximately 10 hours)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States