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

Duke University

Status: Terminated

Conditions: Spine Surgery; Rotational Thrombo-elastometry (ROTEM)

Treatments: Procedure: Spine surgery; Device: ROTEM-based coagulation monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02758184

Pro00070817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

ROTEM Group

Experimental group

Description:

Patients who are randomized to receive ROTEM

Treatment:

Device: ROTEM-based coagulation monitoring

Procedure: Spine surgery

Control Group

Other group

Description:

Patients who are randomized not to receive ROTEM

Treatment:

Procedure: Spine surgery