Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery

Stopped early · Not applicable

Conditions studied: Neuromuscular Scoliosis

In brief

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.

Key facts

Study ID

NCT02670798

Run by

Washington University School of Medicine

People needed

5

Starts

2015-08-01

Expected to finish

2017-07-01

Last updated by the study team

2018-05-03

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria are patients undergoing posterior spinal fusions of 10 or more segments with neuromuscular scoliosis, between the ages of 12 and 18 years old.

You may not qualify if…

• Exclusion criteria include Jehovah's witness status, known preoperative bleeding/coagulation abnormalities, preoperative use of anticoagulants (e.g. Coumadin, enoxaparin), or known blood dyscrasias.

Where it is running

• St. Louis Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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