Clinical trial NCT01536496: Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coagulopathy
Keywords: trauma
hemorrhagic shock
thrombelastography
coagulopathy
transfusion
resuscitation
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Haemonetics Corporation
First posted: 2012-02-22
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28 Day In-hospital Mortality
timeFrame: 28 days in hospital
Secondary outcomes:
measure: Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
timeFrame: Within 24 hours post-injury.
measure: Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
timeFrame: Up to 28 days post-injury.
measure: Time to Death From Injury in Hours.
timeFrame: From time of injury to 28th day of hospitalization.
measure: Change in INR Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in Fibrinogen Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in Platelet Count Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in D-dimer Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in r-TEG ACT (Activated Clotting Time) Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in r-TEG Angle Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in r-TEG Maximal Amplitude (MA) Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Change in r-TEG LY30 Test Results.
timeFrame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
measure: Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
timeFrame: 24 hours post-injury
measure: 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.
timeFrame: 28 days.
measure: Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
timeFrame: Up to 30 days post-injury.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Ernest E. Moore, M.D.
role: PRINCIPAL_INVESTIGATOR
References: