Surgical Blood LossNCT05379530
TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss
A study testing Thromboelastography (TEG) and Anesthesia Provider Survey in people with Surgical Blood Loss and Surgical Hemorrhage, run by Boston Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages Up to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Blood Loss, Surgical Hemorrhage, Post Operative Hemorrhage
- What is being tested?
- Thromboelastography (TEG) and Anesthesia Provider Survey
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- esophageal atresia
- craniotomy/hemispherectomy
- major abdominal surgery
- major hip surgery
- major plastic surgery
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thromboelastography (TEG) and Intraoperative Coagulation Management of Pediatric Patients Undergoing Procedures With High Anticipated Blood Loss
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.
Read the detailed 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:
- 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.
- Being tested
- Thromboelastography (TEG), Anesthesia Provider Survey
- Keywords
- thromboelastography, blood transfusion, viscoelastic test-guided, massive hemorrhage
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SurveyOther
Pre-operative and post-operative provider surveys will be distributed to anesthesiologists caring for study subjects to assess knowledge, practice, and attitudes about TEG.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Thromboelastography (TEG); Other: Anesthesia Provider Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
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.
Measured: 1 year
Tranexamic acid (TXA) use
The investigators will compare tranexamic (TXA) use within specific cohorts between the TEG group and historical matched transfusion data.
Measured: 1 year
Cell salvage use
The investigators will compare cell salvage use within specific cohorts between the TEG group and historical matched transfusion data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2027 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Goobie, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379530
- Sponsor's protocol ID
- P00040518
- Status last verified
- Aug 2026
- First submitted
- 9 May 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastography (TEG) and Intraoperative Coagulation Management of Pediatric Patients Undergoing Procedures With High Anticipated Blood Loss
- ClinicalTrials.gov ID
- NCT05379530
- Acronym / sponsor ID
- P00040518
- Keywords
- thromboelastography, blood transfusion, viscoelastic test-guided, massive hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TEG Arm | Experimental | Diagnostic Test: Thromboelastography (TEG), Other: Anesthesia Provider SurveyAll 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 |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thromboelastography (TEG)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. | Diagnostic test | TEG Arm |
| Anesthesia Provider SurveyPre-operative and post-operative provider surveys will be distributed to anesthesiologists caring for study subjects to assess knowledge, practice, and attitudes about TEG. | Other | TEG Arm |
Primary outcome
Efficacy of utilizing Viscoelastic testing (Thromboelastography;TEG) to diagnose and guide management as measured by type of hemostatic blood products transfused.
Time frame: 1 year
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.
Efficacy of utilizing Viscoelastic testing (TEG) to diagnose and guide intraoperative management as measured by amount (mL/kg) hemostatic blood products transfused.
Time frame: 1 year
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.
4 secondary outcomes
Assess the feasibility of providing and interpreting TEG data in a busy, academic, pediatric non-cardiac operating room
Time frame: 1 year
Red blood cell transfusion amounts
Time frame: 1 year
Tranexamic acid (TXA) use
Time frame: 1 year
Cell salvage use
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastography (TEG) and Anesthesia Provider Survey in people with Surgical Blood Loss and Surgical Hemorrhage, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan M. Goobie, MD, FRCPC (617-355-7737, susan.goobie@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of utilizing Viscoelastic testing (Thromboelastography;TEG) to diagnose and guide management as measured by type of hemostatic blood products transfused. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.