Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery

Neuromuscular Scoliosis Clinical Trial

Official title:

Implementation of a Thromboelastography Guided Transfusion Protocol in Pediatric Neuromuscular Scoliosis Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02670798
• Other study ID #: 201506098
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Scoliosis
• Scoliosis

Intervention

Procedure:
• Thromboelastography laboratory testing
Laboratory test that monitors clotting properties of blood

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Orthopedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss	Amount of blood lost during perioperative period	Day of surgery