Thromboelastography-Guided Fluid Management in Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-12

Study Completion Date

2019-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thromboelastography-derived Functional Fibrinogen Levels

NCT01992757

Focus of Study Coagulation Status of Cardiac Surgery Patient Reducing Excess Blood Transfusion

COMPLETED

Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique

NCT02646254

Myocardial Protection in TOF Repair

COMPLETED PHASE4

Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Spine Surgery

NCT01124474

Surgical Procedures, Operative

TERMINATED NA

Hemodynamic Response During Goal Directed Fluid Therapy in the OR

NCT02365688

Hemodynamic Instability

TERMINATED NA

GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT

NCT03164811

Spine Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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

Control Group

Intervention Type OTHER

Laboratory analysis to guide transfusion

Intervention arm

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

Intervention

Intervention Type PROCEDURE

We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention

We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion

Intervention Type PROCEDURE

Control Group

Laboratory analysis to guide transfusion

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thromboelastography Point of care testing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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