Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery
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|ClinicalTrials.gov Identifier: NCT02670798|
Recruitment Status : Terminated (Expiration of funding)
First Posted : February 2, 2016
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Scoliosis||Procedure: Thromboelastography laboratory testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|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|
No Intervention: Control
Standard of care hematologic management in the operating room
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
- Estimated blood loss [ Time Frame: Day of surgery ]Amount of blood lost during perioperative period
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
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Michael P Kelly, MD||Associate Professor of Orthopedic Surgery|