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Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery

NCT02670798 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-05-03

No results posted yet for this study

Summary

The long-term goal of this study is to optimize the perioperative care of pediatric spinal deformity patients, minimizing perioperative complications and increasing cost-effectiveness of perioperative hematologic management. The objective of the proposed study, which is the initial step in pursuit of this goal, is to evaluate the effectiveness of thromboelastography (TEG) to monitor coagulation pathways and direct blood product replacement in pediatric neuromuscular spinal deformity surgery. The central hypothesis of this study is that TEG will decrease exposure to allogeneic packed red blood cells (PRBC). The rationale is that proven effectiveness of TEG in neuromuscular deformity may change the standard of care for hematologic management in neuromuscular spinal deformity cases and additionally set the stage for a multicenter trial in idiopathic pediatric deformity.

Conditions

  • Neuromuscular Scoliosis

Interventions

PROCEDURE

Thromboelastography laboratory testing

Laboratory test that monitors clotting properties of blood

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Michael P Kelly, MD · Associate Professor of Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670798 on ClinicalTrials.gov