Thromboelastography-Guided Fluid Management in Spinal Surgery

Mayo Clinic

Status: Completed

Conditions: Spinal Fusion

Treatments: Procedure: Intervention; Other: Control Group

Study type: Observational

Funder types: Other

Identifiers

NCT03999086

17-006702

Details and patient eligibility

About

The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.

Full description

Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.

Enrollment: 50 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89

Exclusion criteria

• patients with tumors, infection, or trauma

Trial design

50 participants in 2 patient groups

Control Group

Description:

Traditional evaluation/standard-of-care evaluation of patients undergoing multi-level spinal fusion surgery. These patients will receive point-of-care laboratory testing.

Treatment:

Other: Control Group

Intervention arm

Description:

Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery.

Treatment:

Procedure: Intervention