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TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss

ConditionsSurgical Blood LossSurgical HemorrhagePost Operative Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 20
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pediatric patients undergoing non-cardiac surgery at BCH with a high likelihood of blood transfusion. Specifically these are defined as a surgery with greater than 25% likelihood of transfusion of any non-albumin blood product.

spinal surgery

laparotomy

liver transplant

Disqualifiers

Patients undergoing cardiac surgery or ECMO cannulation, as these surgeries are generally considered outside the scope of general pediatric surgery.

Patients presenting for emergent surgery

Patients undergoing surgeries off hours (between 8pm and 8 am), when TEG analysis is unobtainable

Trial design

Design model

Single group

Treatments tested in this trial

  • Thromboelastography (TEG)

    Diagnostic test

    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.

  • Anesthesia Provider Survey

    Other intervention

    Pre-operative and post-operative provider surveys will be distributed to anesthesiologists caring for study subjects to assess knowledge, practice, and attitudes about TEG.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: TEG ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy of utilizing Viscoelastic testing (Thromboelastography;TEG) to diagnose and guide management as measured by type of hemostatic blood products transfused.

Assess the efficacy of utilizing Viscoelastic testing (TEG) in the diagnosis and management of hemostatic bleeding intraoperatively and compare to the current standard hemostatic product transfusion practice on the management of pediatric patients undergoing specific non-cardiac surgical procedures with high historical rates of transfusions at a single center. The efficacy of TEG will be measured in types of hemostatic blood products (fresh frozen plasma, platelets, cryoprecipitate) transfused within specific high blood loss surgical procedures as compared to historical matches controls which is available in the Department of Anesthesiology Patient Blood Management Database.

Time frame
1 year
2

Efficacy of utilizing Viscoelastic testing (TEG) to diagnose and guide intraoperative management as measured by amount (mL/kg) hemostatic blood products transfused.

Assess the efficacy of utilizing Viscoelastic testing (TEG) in the diagnosis and management of hemostatic bleeding in specific surgical cohorts and compare to the current standard hemostatic product transfusion practice on the management of pediatric patients undergoing specific non-cardiac surgical procedures with high historical rates of transfusions at BCH. The efficacy of TEG will be measured in amount (mL/kg) of hemostatic blood products (fresh frozen plasma, platelets, cryoprecipitate) transfused within specific high blood loss surgical procedures as compared to historical transfusion data ( and standard laboratory data including PT, PTT, INR and fibrinogen and platelets) for the same surgery types available in the Department of Anesthesiology Patient Blood Management Database.

Time frame
1 year

Secondary outcomes

1

Assess the feasibility of providing and interpreting TEG data in a busy, academic, pediatric non-cardiac operating room

Assess the feasibility of providing and interpreting TEG data in a busy, academic, pediatric non-cardiac operating room at relevant clinical time points. Pre-operative and post-operative provider surveys will be distributed to assess knowledge, practice, and attitudes. Surveys responses will be free-form and multiple choice.

Time frame
1 year
2

Red blood cell transfusion amounts

The investigators will also compare red blood cell transfusion (mL/kg) amounts within the specific surgical cohorts between the TEG group and historical matched transfusion data.

Time frame
1 year
3

Tranexamic acid (TXA) use

The investigators will compare tranexamic (TXA) use within specific cohorts between the TEG group and historical matched transfusion data.

Time frame
1 year
4

Cell salvage use

The investigators will compare cell salvage use within specific cohorts between the TEG group and historical matched transfusion data.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: