| Primary | 28 Day In-hospital Mortality | | | Posted | | Number | | participants | | 28 days in hospital | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | | 0.04 | | | | | | 2-Sided | | | | | | | | Superiority or Other | | |
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| Secondary | Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury). | | | Posted | | Number | | deaths | | Within 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury). | | | Posted | | Number | | deaths | | Up to 28 days post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | Time to Death From Injury in Hours. | | | Posted | | Median | Inter-Quartile Range | hours | | From time of injury to 28th day of hospitalization. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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 (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 (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. | | OG001 | 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.: |
|
| Secondary | Change in Fibrinogen Test Results. | | | Posted | | Median | Inter-Quartile Range | mg/dL | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | Control (INR, 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 (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 (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. | | OG001 | 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.: |
|
| Secondary | Change in Platelet Count Test Results. | | | Posted | | Median | Inter-Quartile Range | k/uL | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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 (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 (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. | | OG001 | 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.: |
|
| Secondary | Change in D-dimer Test Results. | | | Posted | | Median | Inter-Quartile Range | ug/mL | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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 (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 (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. | | OG001 | 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.: |
|
| Secondary | Change in r-TEG ACT (Activated Clotting Time) Test Results. | | | Posted | | Median | Inter-Quartile Range | seconds | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | Change in r-TEG Angle Test Results. | | | Posted | | Median | Inter-Quartile Range | degrees | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | Change in r-TEG Maximal Amplitude (MA) Test Results. | | | Posted | | Median | Inter-Quartile Range | mm | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | Change in r-TEG LY30 Test Results. | | | Posted | | Median | Inter-Quartile Range | percent of clot lysis at 30 min. | | Within first 6 hours post-injury, 12 and 24 hours post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | units | | 24 hours post-injury | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | 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. | | | Posted | | Median | Inter-Quartile Range | days | | 28 days. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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.: |
|
| Secondary | 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. | | Posted | | Number | | participants | | Up to 30 days post-injury. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Test (r-TEG) |
|