Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05379530 |
| Other study ID # |
P00040518 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Boston Children's Hospital |
| Contact |
Susan M. Goobie, MD, FRCPC |
| Phone |
617-355-7737 |
| Email |
susan.goobie[@]childrens.harvard.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research team proposes a prospective, observational study to better understand how TEG
can be useful in guiding clinical practice in the Main OR for subject's undergoing high
transfusion risk surgeries.
Intraoperatively, transfusion of blood products is frequently required to restore oxygen
carrying capacity, perfusion and improve coagulation. Both under and over transfusion pose
significant risks, particularly to pediatric patients with small starting intravascular
volumes. Thromboelastography (TEG) is a validated method of dynamically assessing
intraoperative coagulopathy via functional assay. However, while FDA approved and widely used
in the adult setting, TEG is not commonly utilized in the setting of bleeding pediatric
patients.
Recently, TEG has been made available at BCH for clinical purposes and is being used solely
in the cardiac surgery setting. The investigators aim to provide TEG data for non-cardiac
pediatric surgical cases with a high risk of intraoperative blood loss in order to assess the
impact of this tool on intraoperative management.
Description:
Intraoperatively, transfusion of blood products is frequently required to restore oxygen
carrying capacity, perfusion and improve coagulation. Both under and over transfusion pose
significant risks, particularly to pediatric patients with small starting intravascular
volumes. Thromboelastography (TEG) is a type of Viscoelastic testing (ROTEM is another
example) and is a validated point of care method of dynamically assessing intraoperative
coagulopathy via functional assay. It provides more useful information than the commonly used
laboratory values of INR, PT, PTT and Fibrinogen. However, while FDA approved and widely used
in the adult setting, TEG is not commonly utilized in the setting of bleeding pediatric
patients. Recently, TEG has been made available at Boston Children's Hospital (BCH) for
clinical purposes exclusively in the cardiac surgery setting. The investigators aim to
provide TEG data for general main operating room (MOR) pediatric surgical cases with a high
risk of intraoperative blood loss in order to assess the impact of this tool on
intraoperative management of the bleeding patient.
Primary Aim:
Assess the efficacy of providing real time viscoelastic testing (TEG) to anesthesiologists
managing of pediatric patients with hemostatic bleeding undergoing procedures with high
historical rates of blood transfusions. The outcome will be perioperative (intraoperative and
within 24 H postoperative) hemostatic blood product transfusion (type of blood product and
volume mL/g) within specific high blood loss surgical procedures. Data will be compared to
matched cohorts using historical data from the same surgery types available in the Department
of Anesthesia Blood Management Database.
Secondary Aim:
Assess the feasibility of providing real time and interpreting TEG data in a busy, academic,
pediatric main OR at relevant clinical time points. Pre-operative and post-operative surveys
will be administered to clinicians to gauge interest and knowledge in using TEG.
Hypothesis
The hypothesis is that the availability of TEG to help the management of pediatric surgical
patients at a high risk for blood loss will improve targeted transfusion management, decrease
overall intraoperative blood product utilization, and decrease variability in care. This data
may ultimately yield future BCH viscoelastic test-guided (VET) transfusion protocols allowing
a goal-directed approach. Benefits from this approach might translate into:
I. less exposure of the pediatric patient to blood products, thereby reducing the inherent
risks of transfusion such as transfusion reactions, blood product associated infections and
TRALI/TACO II. a reduction in costs, and III. Identification of clinical processes, such as
fibrinolysis, that might otherwise be missed, leading to specific interventions (e.g. use of
antifibrinolytics).
Although different blood product transfusion algorithms have been described in different
clinical settings, there are no current VET (TEG or ROTEM) protocols in use for pediatric MOR
surgical patients at this single center. See Appendix A for both existing BCH massive
hemorrhage guidelines (MHG) and a massive hemorrhage protocol (MHP) including VET guided care
- published as a supplement to the 2019 Society for the advancement of blood management
administrative and clinical standards for patient blood management programs publication6.
These VET MHG will be available to the providers to help diagnosis and guide hemostatic blood
product transfusion management intraoperatively.
