Thromboelastography Transfusion Protocol for Pediatric Neuromuscular Scoliosis Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - 18 |
| Updated: | 5/5/2018 |
| Start Date: | August 2015 |
| End Date: | July 2017 |
Implementation of a Thromboelastography Guided Transfusion Protocol in Pediatric Neuromuscular Scoliosis Surgery
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.
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.
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.
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.
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.
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