An interventional study of Blood product transfusion based on conventional coagulation tests. and Blood product transfusion based on rapid thrombelastography (r-TEG) results. in Acute Coagulopathy, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Diagnostic
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.
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:
Our specific study aims are:
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Exclusion Criteria:
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.
Biological: Blood product transfusion based on conventional coagulation tests.
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.
Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.
Transfusion of blood products.
Transfusion of blood products.
28 Day In-hospital Mortality
Time frame: 28 days in hospital
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.
A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
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
Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
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.
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.
Time frame: Up to 30 days post-injury.
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.
| Milestone | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Started | 57 | 57 |
| Completed | 55 | 56 |
| Not completed | 2 | 1 |
| participants | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| 28 Day In-hospital Mortality | 20 | 11 |
| deaths | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Number of deaths <6 hours from injury | 12 | 4 |
| Number of deaths 6-24 hours from injury | 8 | 7 |
| deaths | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury). | 11 | 5 |
| hours | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Time to Death From Injury in Hours. | 4.2 (1.2 to 9.9) | 10.4 (4.5 to 200.3) |
A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
| units on a scale | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| INR at 6 hours | 1.5 (1.3 to 2.2) | 1.8 (1.3 to 2.1) |
| INR at 12 hours | 1.4 (1.2 to 1.6) | 1.4 (1.3 to 1.9) |
| INR at 24 hours | 1.5 (1.4 to 1.7) | 1.4 (1.3 to 2) |
| mg/dL | Control (INR, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| fibrinogen at 6 hours | 161.5 (112 to 175) | 153 (111 to 180) |
| fibrinogen at 12 hours | 185.5 (159 to 232) | 159 (111 to 214) |
| fibrinogen at 24 hours | 233 (218 to 256) | 203 (150 to 266) |
| k/uL | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| platelet count at 6 hours | 90 (60 to 144) | 100 (89 to 140) |
| platelet count at 12 hours | 116 (75 to 157) | 110 (90 to 139) |
| platelet count at 24 hours | 96.5 (72 to 128) | 109 (91 to 130) |
| ug/mL | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| D-dimer at 6 hours | 8.3 (1 to 15) | 8.7 (2 to 13) |
| D-dimer at 12 hours | 8 (2 to 13) | 6.4 (3 to 13) |
| D-dimer at 24 hours | 5.4 (2 to 13) | 5 (3 to 13) |
| seconds | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| r-TEG ACT at 6 hours | 124 (113 to 142) | 121 (117 to 144) |
| r-TEG ACT at 12 hours | 128 (121 to 144) | 121 (113 to 140) |
| r-TEG ACT at 24 hours | 128 (121 to 128) | 128 (121 to 136) |
| degrees | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| r-TEG Angle at 6 hours | 70.8 (64 to 72) | 68.2 (60 to 73) |
| r-TEG Angle at 12 hours | 68.5 (60 to 70) | 65.5 (57 to 73) |
| r-TEG Angle at 24 hours | 69.1 (61 to 71) | 71.3 (64 to 74) |
| mm | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| r-TEG MA at 6 hours | 53.8 (49 to 59) | 51 (46 to 57) |
| r-TEG MA at 12 hours | 55 (52 to 57) | 56.9 (49 to 58) |
| r-TEG MA at 24 hours | 56.5 (46 to 62) | 56.9 (54 to 61) |
| percent of clot lysis at 30 min. | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| r-TEG LY30 at 6 hours | 0 (0 to 0) | 0 (0 to 1.5) |
| r-TEG LY30 at 12 hours | 0.3 (0 to 0.5) | 0.1 (0.1 to 1.5) |
| r-TEG LY30 at 24 hours | 0.7 (0.2 to 1.6) | 0.7 (0.7 to 1.7) |
Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
| units | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Red blood cell units | 11.0 (6 to 16) | 9.5 (5 to 16) |
| Plasma units | 6.0 (4 to 9) | 5 (3 to 9) |
| Cryoprecipitate units | 1.0 (0 to 2) | 0 (0 to 2) |
| Platelet units | 1 (0 to 2) | 1 (0 to 2) |
| days | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| ICU-free days. | 8.5 (0 to 19.5) | 16 (0 to 22) |
| Ventilator-free days. | 13 (0 to 22) | 18 (0 to 25) |
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.
| participants | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization. | 3 | 2 |
Collected over Up to 28 days of hospitalization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control (INR, PTT, Fibrinogen, D-dimer) | — | 0/55 (0%) | 55/55 (100%) |
| Test (r-TEG) | — | 0/56 (0%) | 56/56 (100%) |
| Event | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) |
|---|---|---|
| Abnormal laboratory findingBlood and lymphatic system disorders | 55/55 | 56/56 |
| Age, Continuous(years) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 38 (25 to 55) | 41 (28 to 54) | 39 (28 to 55) |
| Sex: Female, Male(Participants) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Female | 14 | 19 | 33 |
| Male | 41 | 37 | 78 |
| Injury Severity Score (ISS)(Scores on a scale) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 33 (25 to 43) | 29.5 (23 to 41) | 30 (24 to 43) |
| Base Deficit (BD)(mEq/L) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 13.7 (9 to 18) | 11.0 (9 to 16) | 12.0 (9 to 18) |
| International Normalized Ratio (INR)(units on a scale) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 1.46 (1.2 to 2.3) | 1.45 (1.2 to 1.7) | 1.45 (1.2 to 1.9) |
| Platelet count(k/uL) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 214 (165 to 279) | 214 (145 to 318) | 214 (150 to 291) |
| Fibrinogen(mg/dL) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 113 (68 to 139) | 132 (94 to 240) | 122 (75 to 201) |
| D-dimer(ug/mL) | Control (INR, PTT, Fibrinogen, D-dimer) | Test (r-TEG) | Total |
|---|---|---|---|
| Median | 12.9 (6 to 20) | 10.3 (2 to 20) | 11.1 (4 to 20) |
4 further baseline measures are reported on the registry.
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