Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery

NCT02670798 | Terminated DMC

• 1 other identifier: 201506098
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neuromuscular; scoliosis

Outcome Measures

Primary Outcomes (1)

• Estimated blood loss

  Amount of blood lost during perioperative period

  Day of surgery

Study Arms (2)

Control

NO INTERVENTION

Standard of care hematologic management in the operating room

Study

EXPERIMENTAL

Standard of care hematologic management plus additional monitoring with the intervention of Thromboelastography laboratory testing and use of a thromboelastography-guided transfusion protocol.

Procedure: Thromboelastography laboratory testing

Interventions

Thromboelastography laboratory testing PROCEDURE

Laboratory test that monitors clotting properties of blood

Also known as: TEG

Study

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael P Kelly, MD

  Associate Professor of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: February 2, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)