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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-05-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spine Surgery Rotational Thrombo-elastometry (ROTEM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ROTEM Group

Patients who are randomized to receive ROTEM

Group Type EXPERIMENTAL

ROTEM-based coagulation monitoring

Intervention Type DEVICE

Spine surgery

Intervention Type PROCEDURE

Control Group

Patients who are randomized not to receive ROTEM

Group Type OTHER

Spine surgery

Intervention Type PROCEDURE

Interventions

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ROTEM-based coagulation monitoring

Intervention Type DEVICE

Spine surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No