Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874843
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-04-25
Brief Title:
Validation of Point-of-care Thromboelastography TEG 6s in Pediatric Patients
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Validation of Point-of-care Thromboelastography TEG 6s in Pediatric Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the performance of the TEG6s in normal pediatric patients The main questions it aims to answer are What are the normal TEG 6S lab results in normal pediatric patients and how do they compare to existing published reference ranges Participants and their guardians will be asked to submit a small amount of blood at the beginning of an elective operation for analysis in the TEG 6s machine
Detailed Description:
Trauma is the leading cause of death in children Researchers starting with Trunkey et al have described three general time points of mortality after trauma - in the field early secondary to hemorrhage and late due to infectious complications Early mortality after trauma is specifically linked to hemorrhage Trauma-induced coagulopathy is a multifactorial phenomenon present after trauma in both children and adults that can worsen hemorrhage and ultimately lead to increased mortality Classical laboratory measurements of the coagulation pathway PT PTT INR fibrinogen platelet count have shown derangement after trauma and are correlated with mortality However these traditional tests of coagulation function take time to run as they are drawn and sent to a laboratory for evaluation and therefore provide a delayed snapshot of a potentially evolving coagulopathy scenario Adult trauma centers have increasingly incorporated viscoelastic measures of the coagulation cascade to evaluate for and subsequently treat trauma-induced coagulopathy One such test is thromboelastography TEG which is a whole blood assay that assesses functional clot kinetics and stability It provides information on how various hemostatic factors including coagulation factors platelets and fibrinogen contribute to the clot A 2016 randomized-controlled trial in adult trauma patients who met criteria for the institutions massive transfusion protocol were randomized to transfusion guided by TEG or by conventional measure of coagulopathy The authors found increased survival in the TEG group as well as less transfusion of platelets and fresh frozen plasma
TEG assesses the clot rate clot strength and clot stability which then assists the clinician in choosing appropriate blood component therapy The American College of Surgeons Trauma Quality Improvement Program recommends the use of thromboelastography when patients are at risk for trauma-induced coagulopathy Visicoeslastic evaluation of the coagulation pathway has become the standard of care in adult trauma patients to provide information on a patients coagulation status particularly when the patient is requiring multiple blood products This allows the physician to deliver a targeted hemostatic resuscitation appropriate for the patient needs in real-time This can result in a decrease of blood products and quicker reversal of the trauma induced coagulopathy
Riley Hospital for Children at IU Health has a TEG 5000 machine Haemonetics Corp which performs the coagulation tests needed to help guide the resuscitation of a critical trauma patient While an improvement over previous tests such as INR platelet count PTT the TEG 5000 still takes 45-60 minutes to get the results needed to guide fluidblood resuscitation making the results outdated as the patient has potentially received multiple units of blood products andor had additional bleeding during that time The TEG 5000 machine also has very specific environmental and preparation needs ie flat surface which is not bumped controlled pipetting dropping of blood products into machine as well as mixing of reagents that is very difficult to do in a busy trauma bayemergency department with a critical patient
The TEG 6s assays are performed in a microfluidic cartridge which only requires a small amount of a patients blood be transferred to the cartridge for analysis The vibration frequency of the blood meniscus at which resonance occurs is used to create a clot dynamics tracing The sample is drawn automatically into the testing chambers rather than requiring manual pipetting leading to less user variability This simpler operation provides results in 15-20 minutes making the test more clinically useful in guiding transfusion therapy during active bleeding
TEG 6s and TEG 5000 have been evaluated in adult patients with good agreement between the modalities More specifically the TEG 6s has been validated in adult trauma patients However few pediatric studies exist
TEG assesses the clot rate clot strength and clot stability which then assists the clinician in choosing appropriate blood component therapy The American College of Surgeons Trauma Quality Improvement Program recommends the use of thromboelastography when patients are at risk for trauma-induced coagulopathy Visicoeslastic evaluation of the coagulation pathway has become the standard of care in adult trauma patients to provide information on a patients coagulation status particularly when the patient is requiring multiple blood products This allows the physician to deliver a targeted hemostatic resuscitation appropriate for the patient needs in real-time This can result in a decrease of blood products and quicker reversal of the trauma induced coagulopathy
Riley Hospital for Children at IU Health has a TEG 5000 machine Haemonetics Corp which performs the coagulation tests needed to help guide the resuscitation of a critical trauma patient While an improvement over previous tests such as INR platelet count PTT the TEG 5000 still takes 45-60 minutes to get the results needed to guide fluidblood resuscitation making the results outdated as the patient has potentially received multiple units of blood products andor had additional bleeding during that time The TEG 5000 machine also has very specific environmental and preparation needs ie flat surface which is not bumped controlled pipetting dropping of blood products into machine as well as mixing of reagents that is very difficult to do in a busy trauma bayemergency department with a critical patient
The TEG 6s assays are performed in a microfluidic cartridge which only requires a small amount of a patients blood be transferred to the cartridge for analysis The vibration frequency of the blood meniscus at which resonance occurs is used to create a clot dynamics tracing The sample is drawn automatically into the testing chambers rather than requiring manual pipetting leading to less user variability This simpler operation provides results in 15-20 minutes making the test more clinically useful in guiding transfusion therapy during active bleeding
TEG 6s and TEG 5000 have been evaluated in adult patients with good agreement between the modalities More specifically the TEG 6s has been validated in adult trauma patients However few pediatric studies exist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None