TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss

NCT05379530 | Not Yet Recruiting DMC

• 1 other identifier: P00040518
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Surgical Blood Loss; Surgical Hemorrhage; Post Operative Hemorrhage

Keywords

thromboelastography; blood transfusion; viscoelastic test-guided; massive hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (4)

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

  1 year

• Red blood cell transfusion amounts

  1 year

• Tranexamic acid (TXA) use

  1 year

• Cell salvage use

  1 year

Study Arms (1)

TEG Arm

EXPERIMENTAL

All patients enrolled in the study will have up to four 0.5cc blood samples obtained specifically for TEG analysis at the following defined points (for a total of up to 2cc of blood) when other routine labs are drawn (via an existing intravenous line or arterial line placed for clinical care) : * Once at the beginning of the case * Once at the end of the case * Up to two times at the same time as arterial blood gas (ABG) samples (if drawn) The research team will collect the following information from the electronic medical record and input it into the Internal REDCap database: * De-identified demographic data, including age, height, weight, and diagnosis * Preoperative, intraoperative, and postoperative laboratory values( including PT, PTT, INR and fibrinogen and platelets), as dictated by standard clinical practice * Time of TEG results printed and time delivered to anesthesiologist * Complications/Adverse events within the first 48 hours postoperatively

Diagnostic Test: Thromboelastography (TEG); Other: Anesthesia Provider Survey

Interventions

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.

TEG Arm

Anesthesia Provider Survey OTHER

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

TEG Arm

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Eligible surgeries include:
• spinal surgery
• laparotomy
• liver transplant
• craniofacial surgery
• esophageal atresia
• craniotomy/hemispherectomy
• major abdominal surgery
• major hip surgery
• major plastic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Susan M. Goobie, MD, FRCPC

CONTACT

617-355-7737; susan.goobie@childrens.harvard.edu

Jocelyn Booth, BSN

CONTACT

857-218-4585; jocelyn.booth@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Thromboelastography (TEG) analysis will be done on all subjects who consent to participate in the study. TEG results will be made available to the anesthesiologist caring for the subject and may be used to help guide their care.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share