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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02758184
• Other study ID #: Pro00070817
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 16, 2018

Study information

• Verified date: March 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotational Thrombo-elastometry (ROTEM)
• Spine Surgery

Intervention

Device:
• ROTEM-based coagulation monitoring

Procedure:
• Spine surgery

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Blood Loss (mL)		during surgery (up to approximately 10 hours)
Primary	Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused		up to 48 hours after surgery
Secondary	Length of Hospital Stay After Surgery		typically 5-7 days
Secondary	Cost Analysis, as Measured by Total Dollar Value of Blood Products Used		during surgery (up to approximately 10 hours)
Secondary	Amount of Recovered Blood Transfused During the Procedure (mL)		during surgery (up to approximately 10 hours)
Secondary	Drain Output (mL)		first 24 hours after surgery
Secondary	Amount of Blood Products Transfused, Measured in Units		during surgery (up to approximately 10 hours)
Secondary	Amount of Blood Products Transfused, Measured in Units		48 hours following surgery
Secondary	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)
Secondary	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)
Secondary	Change in Prothrombin Time		Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Secondary	Change in International Normalized Ratio (PT/INR)		Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Secondary	Change in Activated Partial Thromboplastin Time (aPTT)		Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Secondary	Change in Fibrinogen (g/L)		Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)