Trial Outcomes & Findings for Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma (NCT NCT01536496)
NCT ID: NCT01536496
Last Updated: 2019-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
28 days in hospital
Results posted on
2019-01-08
Participant Flow
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.
Participant milestones
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
55
|
56
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
Baseline characteristics by cohort
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
|
Test (r-TEG)
n=56 Participants
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=5 Participants
|
41 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Injury Severity Score (ISS)
|
33 Scores on a scale
n=5 Participants
|
29.5 Scores on a scale
n=7 Participants
|
30 Scores on a scale
n=5 Participants
|
|
Base Deficit (BD)
|
13.7 mEq/L
n=5 Participants
|
11.0 mEq/L
n=7 Participants
|
12.0 mEq/L
n=5 Participants
|
|
International Normalized Ratio (INR)
|
1.46 units on a scale
n=5 Participants
|
1.45 units on a scale
n=7 Participants
|
1.45 units on a scale
n=5 Participants
|
|
Platelet count
|
214 k/uL
n=5 Participants
|
214 k/uL
n=7 Participants
|
214 k/uL
n=5 Participants
|
|
Fibrinogen
|
113 mg/dL
n=5 Participants
|
132 mg/dL
n=7 Participants
|
122 mg/dL
n=5 Participants
|
|
D-dimer
|
12.9 ug/mL
n=5 Participants
|
10.3 ug/mL
n=7 Participants
|
11.1 ug/mL
n=5 Participants
|
|
TEG ACT (activated clotting time)
|
128 seconds
n=5 Participants
|
128 seconds
n=7 Participants
|
128 seconds
n=5 Participants
|
|
TEG Angle
|
50.9 degrees
n=5 Participants
|
52.3 degrees
n=7 Participants
|
51.5 degrees
n=5 Participants
|
|
TEG MA (maximal amplitude)
|
47.5 mm
n=5 Participants
|
53.9 mm
n=7 Participants
|
50.9 mm
n=5 Participants
|
|
TEG LY30
|
0.5 percent of clot lysis at 30 minutes
n=5 Participants
|
1.2 percent of clot lysis at 30 minutes
n=7 Participants
|
0.9 percent of clot lysis at 30 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days in hospitalOutcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
28 Day In-hospital Mortality
|
20 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Within 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Number of deaths <6 hours from injury
|
12 deaths
|
4 deaths
|
|
Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).
Number of deaths 6-24 hours from injury
|
8 deaths
|
7 deaths
|
SECONDARY outcome
Timeframe: Up to 28 days post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).
|
11 deaths
|
5 deaths
|
SECONDARY outcome
Timeframe: From time of injury to 28th day of hospitalization.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=20 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=11 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Time to Death From Injury in Hours.
|
4.2 hours
Interval 1.2 to 9.9
|
10.4 hours
Interval 4.5 to 200.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in INR Test Results.
INR at 6 hours
|
1.5 units on a scale
Interval 1.3 to 2.2
|
1.8 units on a scale
Interval 1.3 to 2.1
|
|
Change in INR Test Results.
INR at 12 hours
|
1.4 units on a scale
Interval 1.2 to 1.6
|
1.4 units on a scale
Interval 1.3 to 1.9
|
|
Change in INR Test Results.
INR at 24 hours
|
1.5 units on a scale
Interval 1.4 to 1.7
|
1.4 units on a scale
Interval 1.3 to 2.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in Fibrinogen Test Results.
fibrinogen at 6 hours
|
161.5 mg/dL
Interval 112.0 to 175.0
|
153 mg/dL
Interval 111.0 to 180.0
|
|
Change in Fibrinogen Test Results.
fibrinogen at 12 hours
|
185.5 mg/dL
Interval 159.0 to 232.0
|
159 mg/dL
Interval 111.0 to 214.0
|
|
Change in Fibrinogen Test Results.
fibrinogen at 24 hours
|
233 mg/dL
Interval 218.0 to 256.0
|
203 mg/dL
Interval 150.0 to 266.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in Platelet Count Test Results.
platelet count at 6 hours
|
90 k/uL
Interval 60.0 to 144.0
|
100 k/uL
Interval 89.0 to 140.0
|
|
Change in Platelet Count Test Results.
platelet count at 12 hours
|
116 k/uL
Interval 75.0 to 157.0
|
110 k/uL
Interval 90.0 to 139.0
|
|
Change in Platelet Count Test Results.
platelet count at 24 hours
|
96.5 k/uL
Interval 72.0 to 128.0
|
109 k/uL
Interval 91.0 to 130.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in D-dimer Test Results.
D-dimer at 6 hours
|
8.3 ug/mL
Interval 1.0 to 15.0
|
8.7 ug/mL
Interval 2.0 to 13.0
|
|
Change in D-dimer Test Results.
D-dimer at 12 hours
|
8 ug/mL
Interval 2.0 to 13.0
|
6.4 ug/mL
Interval 3.0 to 13.0
|
|
Change in D-dimer Test Results.
D-dimer at 24 hours
|
5.4 ug/mL
Interval 2.0 to 13.0
|
5 ug/mL
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in r-TEG ACT (Activated Clotting Time) Test Results.
r-TEG ACT at 6 hours
|
124 seconds
Interval 113.0 to 142.0
|
121 seconds
Interval 117.0 to 144.0
|
|
Change in r-TEG ACT (Activated Clotting Time) Test Results.
r-TEG ACT at 12 hours
|
128 seconds
Interval 121.0 to 144.0
|
121 seconds
Interval 113.0 to 140.0
|
|
Change in r-TEG ACT (Activated Clotting Time) Test Results.
r-TEG ACT at 24 hours
|
128 seconds
Interval 121.0 to 128.0
|
128 seconds
Interval 121.0 to 136.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in r-TEG Angle Test Results.
r-TEG Angle at 6 hours
|
70.8 degrees
Interval 64.0 to 72.0
|
68.2 degrees
Interval 60.0 to 73.0
|
|
Change in r-TEG Angle Test Results.
r-TEG Angle at 12 hours
|
68.5 degrees
Interval 60.0 to 70.0
|
65.5 degrees
Interval 57.0 to 73.0
|
|
Change in r-TEG Angle Test Results.
r-TEG Angle at 24 hours
|
69.1 degrees
Interval 61.0 to 71.0
|
71.3 degrees
Interval 64.0 to 74.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in r-TEG Maximal Amplitude (MA) Test Results.
r-TEG MA at 6 hours
|
53.8 mm
Interval 49.0 to 59.0
|
51 mm
Interval 46.0 to 57.0
|
|
Change in r-TEG Maximal Amplitude (MA) Test Results.
r-TEG MA at 12 hours
|
55 mm
Interval 52.0 to 57.0
|
56.9 mm
Interval 49.0 to 58.0
|
|
Change in r-TEG Maximal Amplitude (MA) Test Results.
r-TEG MA at 24 hours
|
56.5 mm
Interval 46.0 to 62.0
|
56.9 mm
Interval 54.0 to 61.0
|
SECONDARY outcome
Timeframe: Within first 6 hours post-injury, 12 and 24 hours post-injury.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Change in r-TEG LY30 Test Results.
r-TEG LY30 at 6 hours
|
0 percent of clot lysis at 30 min.
Interval 0.0 to 0.0
|
0 percent of clot lysis at 30 min.
Interval 0.0 to 1.5
|
|
Change in r-TEG LY30 Test Results.
r-TEG LY30 at 12 hours
|
0.3 percent of clot lysis at 30 min.
Interval 0.0 to 0.5
|
0.1 percent of clot lysis at 30 min.
Interval 0.1 to 1.5
|
|
Change in r-TEG LY30 Test Results.
r-TEG LY30 at 24 hours
|
0.7 percent of clot lysis at 30 min.
Interval 0.2 to 1.6
|
0.7 percent of clot lysis at 30 min.
Interval 0.7 to 1.7
|
SECONDARY outcome
Timeframe: 24 hours post-injuryAmount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.
Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Red blood cell units
|
11.0 units
Interval 6.0 to 16.0
|
9.5 units
Interval 5.0 to 16.0
|
|
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Plasma units
|
6.0 units
Interval 4.0 to 9.0
|
5 units
Interval 3.0 to 9.0
|
|
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Cryoprecipitate units
|
1.0 units
Interval 0.0 to 2.0
|
0 units
Interval 0.0 to 2.0
|
|
Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury
Platelet units
|
1 units
Interval 0.0 to 2.0
|
1 units
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 28 days.Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
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.
ICU-free days.
|
8.5 days
Interval 0.0 to 19.5
|
16 days
Interval 0.0 to 22.0
|
|
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.
Ventilator-free days.
|
13 days
Interval 0.0 to 22.0
|
18 days
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 Participants
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 Participants
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.
|
3 participants
|
2 participants
|
Adverse Events
Control (INR, PTT, Fibrinogen, D-dimer)
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Test (r-TEG)
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control (INR, PTT, Fibrinogen, D-dimer)
n=55 participants at risk
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.
Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products.
|
Test (r-TEG)
n=56 participants at risk
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.
Blood product transfusion based on rapid thrombelastography (r-TEG) results.:
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal laboratory finding
|
100.0%
55/55 • Number of events 55 • Up to 28 days of hospitalization.
|
100.0%
56/56 • Number of events 56 • Up to 28 days of hospitalization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place