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 |
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.
(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.
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.
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