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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:2/1/2019
Start Date:June 2016
End Date:July 2019
Contact:Sergio Mendoza-Lattes
Phone:9196608267

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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.

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.

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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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