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Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670798
Recruitment Status : Terminated (Expiration of funding)
First Posted : February 2, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Scoliosis Procedure: Thromboelastography laboratory testing Not Applicable

Detailed Description:

To achieve the aims of this study, the investigators will perform a randomized clinical trial comparing thromboelastography with standard intraoperative monitoring of coagulation pathways in pediatric neuromuscular deformity surgery. All patients will receive the standard of care hematological management, including intravenous tranexamic acid (50mg/kg loading bolus, 5mg/kg/hr infusion until wound closure) during surgery. Patients randomized to the TEG group will receive standard of care plus TEG tests at four time points: at the time of incision, at completion of surgical exposure, at completion of instrumentation, and upon arrival to the PACU. TEG results will be used to guide fluid replacement, in the form of platelets, fresh frozen plasma, cryoprecipitate, or more tranexamic acid according to previously published protocols9. Data collected will include standard preoperative demographic data: gender, age, body mass index, diagnosis; standard spinal deformity radiographic measurements; and surgical data including operative time, estimated blood loss, and blood product replacement. The international normalized ratio (INR) will be obtained at wound closure, along with a complete blood count, for both groups as per standard of care. Postoperative data points collected will include allogeneic packed red cell transfusion volume, drain output (all drains discontinued on postoperative day #3), time to normal feeding (either home feeding tube rate or normal per os diet), and time to discharge. Perioperative complications will be collected and categorized according to Glassman et al.

Cost data related to the hospital stay and care of any perioperative complications data will be recorded. These will include costs related to antibiotics, length of stay (including prolonged intensive care unit stay), and perioperative transfusion requirements. To approximate the costs related to transfusion, the investigators will include costs of acquisition, storage, and administration. Similar costs related to any other blood product administration will be collected and assigned as needed. The investigators anticipate that patient reported quality of life scores will be similar between groups. As this may not be the case, the investigators will collect quality adjusted life year (QALY) data through the ACEND survey. These data will be collected at the preoperative visit and at the 6, 12, and 24 month followup points.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Implementation of a Thromboelastography Guided Transfusion Protocol in Pediatric Neuromuscular Scoliosis Surgery
Study Start Date : August 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Standard of care hematologic management in the operating room
Experimental: Study
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
Laboratory test that monitors clotting properties of blood
Other Name: TEG




Primary Outcome Measures :
  1. Estimated blood loss [ Time Frame: Day of surgery ]
    Amount of blood lost during perioperative period



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670798


Locations
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United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Orthopedic Research and Education Foundation
Investigators
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Principal Investigator: Michael P Kelly, MD Associate Professor of Orthopedic Surgery
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02670798    
Other Study ID Numbers: 201506098
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Washington University School of Medicine:
neuromuscular
scoliosis
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases