Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma

A Prospective, Randomized Comparison Of Rapid Thrombelastography (r-TEG) And Conventional Coagulation Testing For Guiding The Diagnosis And Haemostatic Resuscitation Of Trauma Patients At Risk For Post-Injury Coagulopathy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01536496

Enrollment

114

Registered

2012-02-22

Start date

2010-09-30

Completion date

2014-07-31

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coagulopathy

Keywords

trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation

Brief summary

The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional coagulation testing for diagnosing and treating coagulation abnormalities in severely injured patients who are likely to require transfusion therapy.

Detailed description

This is a prospective, randomized study comparing rapid thrombelastography (r-TEG) with conventional coagulation testing for diagnosing post-injury coagulopathy and guiding haemostatic resuscitation strategy in severely injured patients arriving at the trauma center who are likely to require transfusion therapy. Our global hypothesis is that: 1. r-TEG is an effective tool for early identification of specific coagulation abnormalities via real time analysis, providing rapid results at the point of care (POC), 2. r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon individual patient deficits, 3. r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets in the individual trauma patient, 4. r-TEG will result in reduced transfusion requirements in patients with post-injury coagulopathy. Our specific study aims are: 1. To compare r-TEG parameters \[TEG-ACT, alpha angle, K value, MA (maximum amplitude), G value (clot strength), and fibrinolysis (EPL=estimated percent lysis)\] with conventional coagulation testing \[aPTT, INR, platelet count, fibrinogen level, D-dimer\] in their ability to diagnose and monitor coagulation abnormalities in the trauma patient specifically. 2. To compare blood product administration (packed red blood cells, fresh frozen plasma, cryoprecipitate and apheresis platelets) in the first 24 hours post-injury when transfusion is guided by r-TEG versus conventional coagulation tests. 3. To determine whether normalization of r-TEG values predicts cessation of coagulopathic bleeding better than normalization of conventional clinical coagulation tests based upon clinical impressions of the treating surgeons and review of operative records and outcome. 4. To determine and compare patterns of transfusion ratios of packed red blood cells: fresh frozen plasma: platelets for resuscitation of patients with post-injury coagulopathy in the r-TEG versus conventional coagulation test guided groups for the first 24 hours post-injury. 5. To determine and compare the timeframes of blood product administration throughout the first 24 hours post-injury when transfusion is guided by r-TEG versus conventional coagulation testing. 6. To compare the incidence of hemorrhage-related deaths as: very early mortality (\<2 hours post-injury), early (2\<6 hours post-injury) and delayed (6-24 post-injury) based upon review of death/autopsy records for date, time and cause of death in patients whose resuscitation is guided by r-TEG versus conventional coagulation testing. 7. To compare a) the incidence of transfusion associated lung injury (TRALI), transfusion associated circulatory overload (TACO), acute respiratory distress syndrome (ARDS), and multiple organ failure (MOF); b) the length of stay in the surgical intensive care unit (SICU) and the number of ventilator free days in the SICU; and c) late mortality (\>24 hour to Day 30), including day number and cause of death, in patients whose resuscitation is guided by r-TEG versus conventional coagulation testing.

Interventions

BIOLOGICALBlood product transfusion based on conventional coagulation tests.

Transfusion of blood products.

BIOLOGICALBlood product transfusion based on rapid thrombelastography (r-TEG) results.

Transfusion of blood products.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female, age \>18 years admitted to Denver Health Medical Center. 2. Blunt or penetrating trauma sustained \< 6 hours before admission, with Injury Severity Score \> 15 (ISS\>15), likely to require transfusion of RBC within 6 hours from admission as indicated by clinical assessment.

Exclusion criteria

1. Age \< 18 years. 2. Documented chronic liver disease (total bilirubin \>2.0 mg/dL). Advanced cirrhosis discovered on laparotomy will be a criterion for study withdrawal and exclusion of conventional coagulation or r-TEG/TEG data from the analysis). 3. Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease). 4. Prisoner. 5. Pregnancy.

Design outcomes

Primary

Measure	Time frame
28 Day In-hospital Mortality	28 days in hospital

Secondary

Measure	Time frame	Description
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).	Up to 28 days post-injury.	—
Time to Death From Injury in Hours.	From time of injury to 28th day of hospitalization.	—
Change in INR Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Change in Fibrinogen Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Change in Platelet Count Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Change in D-dimer Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).	Within 24 hours post-injury.	—
Change in r-TEG Angle Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Change in r-TEG Maximal Amplitude (MA) Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Change in r-TEG LY30 Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury	24 hours post-injury	Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.	28 days.	—
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.	Up to 30 days post-injury.	Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.
Change in r-TEG ACT (Activated Clotting Time) Test Results.	Within first 6 hours post-injury, 12 and 24 hours post-injury.	—

Countries

United States

Participant flow

Recruitment details

The first patient was enrolled on 09/25/2010 and the last one was enrolled on 03/21/2014. The patients were enrolled when they met the inclusion criteria for the study, which were the criteria that activate the massive transfusion protocol. Enrollment occured upon arrival either in Emergency Room or in Operating Room.

Participants by arm

Arm	Count
Control (INR, PTT, Fibrinogen, D-dimer)	55
Test (r-TEG)	56
Total	111

Baseline characteristics

Characteristic	Total	Control (INR, PTT, Fibrinogen, D-dimer)	Test (r-TEG)
Age, Continuous	39 years	38 years	41 years
Base Deficit (BD)	12.0 mEq/L	13.7 mEq/L	11.0 mEq/L
D-dimer	11.1 ug/mL	12.9 ug/mL	10.3 ug/mL
Fibrinogen	122 mg/dL	113 mg/dL	132 mg/dL
Injury Severity Score (ISS)	30 Scores on a scale	33 Scores on a scale	29.5 Scores on a scale
International Normalized Ratio (INR)	1.45 units on a scale	1.46 units on a scale	1.45 units on a scale
Platelet count	214 k/uL	214 k/uL	214 k/uL
Sex: Female, Male Female	33 Participants	14 Participants	19 Participants
Sex: Female, Male Male	78 Participants	41 Participants	37 Participants
TEG ACT (activated clotting time)	128 seconds	128 seconds	128 seconds
TEG Angle	51.5 degrees	50.9 degrees	52.3 degrees
TEG LY30	0.9 percent of clot lysis at 30 minutes	0.5 percent of clot lysis at 30 minutes	1.2 percent of clot lysis at 30 minutes
TEG MA (maximal amplitude)	50.9 mm	47.5 mm	53.9 mm

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	55 / 55	56 / 56
serious Total, serious adverse events	0 / 55	0 / 56

Outcome results

Primary

28 Day In-hospital Mortality

Time frame: 28 days in hospital

Arm	Measure	Value (NUMBER)
Control (INR, PTT, Fibrinogen, D-dimer)	28 Day In-hospital Mortality	20 participants
Test (r-TEG)	28 Day In-hospital Mortality	11 participants

Comparison: Chi-square testp-value: 0.04Chi-squared

Secondary