None listed
Conditions
Brief summary
Coagulopathy is a well recognised sequela of severe TBI, and is frequently associated with prolonged intensive care unit stays and poor patient outcomes. Studies have shown that the mere presence of a coagulopathy was found to increase the likelihood of a poor outcome by a factor of 36 and the odds of mortality up to nine-fold. A meta-analysis done by Harhangi et al quotes the incidence of coagulopathy in TBI to be one in three patients, however varying reports document a incidence rate that ranges from between 10 to 100%. We would like to investigate the true incidence of coagulopathy following severe, isolated traumatic brain injury in the South African population and compare the results based on the mechanism of injury (i.e. blunt TBI vs penetrating TBI). Thromboelastography (TEG) may be used as a tool for the global assessment of coagulation due to its unique ability to identify and assess all phases of haemostasis, thus allowing for the diagnosis of both hypo- and hyper-coagulable states. Native TEG has been extensively validated in trauma-induced coagulopathy as a point-of-care test, and has been used effectively to identify transfusion triggers in such patients. Determining the prevalence hyper-coagulability as detected by TEG and comparing it with that detected with conventional laboratory values, may be beneficial in determining the need for anticoagulation in patients with TBI, as the risk for venous thromboembolism in these patients has been found to be three- to four-fold higher than trauma patients without TBI. If TEG is found to be more sensitive than conventional laboratory testing in detecting hyper-coagulability in these patients, it may become the standard of care in the future. TEG associated hypo-coagulopathy has been shown to be a predictor of poor outcome (increased mortality, fewer ICU-free and hospital-free days) in patients with TBI. Furthermore, such hypo-coagulopathy has been linked with an increased need for neurosurgical intervention. The presence of coagulation abnormalities in patients undergoing emergent neurosurgery may critically affect the patients’ course, both in theatre and postoperatively. Prior knowledge of the presence of any coagulation abnormalities would lead to improved management in the peri-operative period, and hence contribute to the prevention of any secondary insults. This may, in turn, lead to an improved outcome, decreased length of stay and may help to minimise unnecessary transfusion of blood and blood products. The purpose of this study is to detect the prevalence of coagulopathy in patients with severe, isolated traumatic brain injury in Cape Town, and to compare this to the published literature. Secondary outcomes will be to compare the prevalence of any changes between the group of patients with a closed versus penetrating TBI. We will be using standard coagulation screening (platelet count, INR and PTT) as well as a validated point of care coagulation screening test, the TEG.
Interventions
Severe and isolated Traumatic Brain Injury patients, as defined by a GCS of less than or equal to 8/15 at any point in the first 12 (+- 3 hours) with radiological confirmation injury on CT brain. The time of injury will be taken as time zero. If this is unknown, the time of first medical contact (i.e Ambulance pick-up) or time of referral from secondary centre will be taken as time zero. Coagulation studies (TEG and INR, PTT, platelet count, serum urea) will be done at 12 hours (+- 3 hours), and
Severe and isolated Traumatic Brain Injury patients, as defined by a GCS of less than or equal to 8/15 at any point in the first 12 (+- 3 hours) with radiological confirmation injury on CT brain. The time of injury will be taken as time zero. If this is unknown, the time of first medical contact (i.e Ambulance pick-up) or time of referral from secondary centre will be taken as time zero. Coagulation studies (TEG and INR, PTT, platelet count, serum urea) will be done at 12 hours (+- 3 hours), and 36 hours (+- 3 hours). If the 36 hour results are markedly abnormal, another final set of test will be done at 60 hours post injury. We will look for any evidence of coagulopathy as specified by the criteria below. We would like to note whether the same patients are determined to be coagulopathic according to standard TEG criteria and the laboratory defined abnormal values. If there is a difference in the prevalence of coagulopathy between standard testing (INR, PTT, platelet count) and TEG we will note any difference in sensitivities. The criteria to determine the presence of a coagulopathy will be any one of the following: 1. Platelet count < 120 x 10^9 / ml 2. INR > 1.2 3. PTT > 37 seconds 4. TEG (any one of the following): R time <4 minutes or > 8 minutes K time > 4 minutes a angle < 47 degrees or > 74 degrees MA < 54 mm or > 72 mm EPL> 15% LY30 >8% CI< -3 or > 3 The criteria for repeat sampling at 60 hours (+- 3 hours) are any one of the following: (+- 20 % outside of the normal values for coagulation testing and +- 10% outside the normal values for electrolytes) 1. Platelet count < 100 x 10^9 / ml or > 540 x 10^9 / ml 2. INR < 0.6 or > 1,4 3. PTT < 16 seconds or > 43 seconds 4. TEG R time < 3 minutes or > 10 minutes K time > 5 minutes a angle < 38 degrees or > 88 degrees CI < -4 or > 4 EPL > 20% LY30 > 10% 5. Sodium < 122 mmol/l or > 159 mmol/l
Sponsors
Dr Anthony Reed
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Isolated head injury - Abbreviated Injury Score (AIS) >3 for head; AIS <3 for body GCS less than or equal to 8/15 Age > 18 years
Exclusion criteria
Age <18 years Significant other injuries, resulting in a body AIS score of >3 Head AIS < 3 Receipt of blood or blood products prior to admission to the study Patients who have received tranexamic acid prior to admission to the study Known coagulation abnormalities, including patients on therapeutic warfarin, enoxaparin, clopidogrel or aspirin
Outcome results
None listed