Acute CoagulopathyNCT01536496
Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
A study testing Blood product transfusion based on conventional coagulation tests. and Blood product transfusion based on rapid thrombelastography (r-TEG) results. in people with Acute Coagulopathy, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coagulopathy
- What is being tested?
- Blood product transfusion based on conventional coagulation tests. and Blood product transfusion based on rapid thrombelastography (r-TEG) results.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age >18 years admitted to Denver Health Medical Center.
- 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.
Who cannot join
- Age < 18 years.
- 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).
- Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease).
- Prisoner.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
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
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.
Read the 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:
- 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),
- r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon individual patient deficits,
- r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets in the individual trauma patient,
- r-TEG will result in reduced transfusion requirements in patients with post-injury coagulopathy.
Our specific study aims are:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Acute Coagulopathy
- Being tested
- Blood product transfusion based on conventional coagulation tests., Blood product transfusion based on rapid thrombelastography (r-TEG) results.
- Keywords
- trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation
- Medical subject headings
- Wounds and Injuries, Shock, Hemorrhagic, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood product transfusion based on conventional coagulation tests.Biological
Transfusion of blood products.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.Biological
Transfusion of blood products.
| Study group | Role | What they receive |
|---|---|---|
| Control (INR, PTT, fibrinogen, D-dimer) | Active comparator | Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested. Receives: Biological: Blood product transfusion based on conventional coagulation tests. |
| Test (r-TEG) | Active comparator | Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested. Receives: Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 Day In-hospital Mortality
Measured: 28 days in hospital
Secondary outcomes (14)
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Measured: Within 24 hours post-injury.
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
Measured: Up to 28 days post-injury.
Time to Death From Injury in Hours.
Measured: From time of injury to 28th day of hospitalization.
Change in INR Test Results.
A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in Fibrinogen Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in Platelet Count Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in D-dimer Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG ACT (Activated Clotting Time) Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG Angle Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG Maximal Amplitude (MA) Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG LY30 Test Results.
Measured: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Measured: 24 hours post-injury
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.
Measured: 28 days.
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
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.
Measured: Up to 30 days post-injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute CoagulopathyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Haemonetics Corporation
- Responsible party
- Principal investigator, Ernest E. Moore, MD, Denver Health and Hospital Authority
- Investigators
- Ernest E. Moore, M.D., Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536496
- Sponsor's protocol ID
- COMIRB # 10-0477
- Status last verified
- Dec 2018
- First submitted
- 19 Jul 2011
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01536496
- Acronym / sponsor ID
- COMIRB # 10-0477
- Conditions
- Acute Coagulopathy
- Keywords
- trauma, hemorrhagic shock, thrombelastography, coagulopathy, transfusion, resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Haemonetics Corporation
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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),
- r-TEG can be used to guide resuscitation strategy by permitting transfusion based upon individual patient deficits,
- r-TEG will result in appropriate transfusion of plasma, cryoprecipitate, and platelets in the individual trauma patient,
- r-TEG will result in reduced transfusion requirements in patients with post-injury coagulopathy.
Our specific study aims are:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (INR, PTT, fibrinogen, D-dimer) | Active comparator | Biological: Blood product transfusion based on conventional coagulation tests.Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested. |
| Test (r-TEG) | Active comparator | Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, age >18 years admitted to Denver Health Medical Center.
- 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.
Key exclusion criteria (5 listed)
- Age < 18 years.
- 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).
- Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease).
- Prisoner.
- Pregnancy.
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 |
|---|---|---|
| Blood product transfusion based on conventional coagulation tests.Transfusion of blood products. | Biological | Control (INR, PTT, fibrinogen, D-dimer) |
| Blood product transfusion based on rapid thrombelastography (r-TEG) results.Transfusion of blood products. | Biological | Test (r-TEG) |
Primary outcome
28 Day In-hospital Mortality
Time frame: 28 days in hospital
14 secondary outcomes
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Time frame: Within 24 hours post-injury.
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
Time frame: Up to 28 days post-injury.
Time to Death From Injury in Hours.
Time frame: From time of injury to 28th day of hospitalization.
Change in INR Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in Fibrinogen Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in Platelet Count Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in D-dimer Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG ACT (Activated Clotting Time) Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG Angle Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG Maximal Amplitude (MA) Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Change in r-TEG LY30 Test Results.
Time frame: Within first 6 hours post-injury, 12 and 24 hours post-injury.
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Time frame: 24 hours post-injury
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.
Time frame: 28 days.
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
Time frame: Up to 30 days post-injury.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Ernest E. Moore, M.D. principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood product transfusion based on conventional coagulation tests. and Blood product transfusion based on rapid thrombelastography (r-TEG) results. in people with Acute Coagulopathy, run by Denver Health and Hospital Authority at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 Day In-hospital Mortality (time frame: 28 days in hospital). 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 8 Jan 2019.