Phase II Clinical Trial of Atorvastatin in Mild Traumatic Brain Injury

2017 ◽  
Vol 34 (7) ◽  
pp. 1394-1401 ◽  
Author(s):  
Claudia S. Robertson ◽  
James J. McCarthy ◽  
Emmy R. Miller ◽  
Harvey Levin ◽  
Stephen R. McCauley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Mild Traumatic Brain Injury ◽  
Phase Ii ◽  
Phase Ii Clinical Trial

Phase II Clinical Trial of Moderate Hypothermia after Severe Traumatic Brain Injury in Children

Neurosurgery ◽  
2005 ◽  
Vol 56 (4) ◽  
pp. 740-754 ◽  
Author(s):  
P David Adelson ◽  
John Ragheb ◽  
J Paul Muizelaar ◽  
Paul Kanev ◽  
Douglas Brockmeyer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Phase Ii ◽  
Severe Traumatic Brain Injury ◽  
Phase Ii Clinical Trial ◽  
Moderate Hypothermia

scholarly journals Actualization of effective stratified therapy in patients with mild traumatic brain injury (clinical trial)

2018 ◽  
Vol 20 (2) ◽  
pp. 69-77
Author(s):  
I.N. Samartsev ◽  
◽  
S.A. Zhivolupov ◽  
E.V. Jakovlev ◽  
◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Mild Traumatic Brain Injury

scholarly journals Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial

2017 ◽  
Vol 34 (2) ◽  
pp. 313-321 ◽  
Author(s):  
Kathleen R. Bell ◽  
Jesse R. Fann ◽  
Jo Ann Brockway ◽  
Wesley R. Cole ◽  
Nigel E. Bush ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Problem Solving ◽  
Randomized Clinical Trial ◽  
Mild Traumatic Brain Injury ◽  
Service Members

scholarly journals Serum biomarkers as predictors of long-term outcome in severe traumatic brain injury: analysis from a randomized placebo-controlled Phase II clinical trial

2016 ◽  
Vol 125 (3) ◽  
pp. 631-641 ◽  
Author(s):  
Amol Raheja ◽  
Sumit Sinha ◽  
Neha Samson ◽  
Sanjeev Bhoi ◽  
Arulselvi Subramanian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Logistic Regression ◽  
Brain Injury ◽  
Phase Ii ◽  
Severe Traumatic Brain Injury ◽  
Serum Levels ◽  
Serum Biomarkers ◽  
Predictors Of Outcome

OBJECTIVE There has been increased interest in the potential importance of biochemical parameters as predictors of outcome in severe traumatic brain injury (sTBI). METHODS Of 107 patients with sTBI (age 18–65 years with a Glasgow Coma Scale score of 4–8 presenting within 8 hours after injury) who were randomized for a placebo-controlled Phase II trial of progesterone with or without hypothermia, the authors serially analyzed serum biomarkers (S100-B, glial fibrillary acidic protein [GFAP], neuron-specific enolase [NSE], tumor necrosis factor–α, interleukin-6 [IL-6], estrogen [Eg], and progesterone [Pg]). This analysis was performed using the sandwich enzyme-linked immunosorbent assay technique at admission and 7 days later for 86 patients, irrespective of assigned group. The long-term predictive values of serum biomarkers for dichotomized Glasgow Outcome Scale (GOS) score, functional independence measure, and survival status at 6 and 12 months were analyzed using an adjusted binary logistic regression model and receiver operating characteristic curve. RESULTS A favorable GOS score (4–5) at 1 year was predicted by higher admission IL-6 (above 108.36 pg/ml; area under the curve [AUC] 0.69, sensitivity 52%, and specificity 78.6%) and Day 7 Pg levels (above 3.15 ng/ml; AUC 0.79, sensitivity 70%, and specificity 92.9%). An unfavorable GOS score (1–3) at 1 year was predicted by higher Day 7 GFAP levels (above 9.50 ng/ml; AUC 0.82, sensitivity 78.6%, and specificity 82.4%). Survivors at 1 year had significantly higher Day 7 Pg levels (above 3.15 ng/ml; AUC 0.78, sensitivity 66.7%, and specificity 90.9%). Nonsurvivors at 1 year had significantly higher Day 7 GFAP serum levels (above 11.14 ng/ml; AUC 0.81, sensitivity 81.8%, and specificity 88.9%) and Day 7 IL-6 serum levels (above 71.26 pg/ml; AUC 0.87, sensitivity 81.8%, and specificity 87%). In multivariate logistic regression analysis, independent predictors of outcome at 1 year were serum levels of Day 7 Pg (favorable GOS—OR 3.24, CI 1.5–7, p = 0.003; and favorable survival—OR 2, CI 1.2–3.5, p = 0.01); admission IL-6 (favorable GOS—OR 1.04, CI 1.00–1.08, p = 0.04); and Day 7 GFAP (unfavorable GOS—OR 0.79, CI 0.65–0.95, p = 0.01; and unfavorable survival—OR 0.80, CI 0.66–0.96, p = 0.01). CONCLUSIONS Serial Pg, GFAP, and IL-6 monitoring could aid in prognosticating outcomes in patients with acute sTBI. A cause and effect relationship or a mere association of these biomarkers to outcome needs to be further studied for better understanding of the pathophysiology of sTBI and for choosing potential therapeutic targets. Clinical trial registration no.: CTRI/2009/091/000893 (http://www.ctri.nic.in).

scholarly journals CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomized controlled phase II clinical trial

2020 ◽  
Author(s):  
Inez Koopman ◽  
Gabriel J.E. Rinkel ◽  
Mervyn D.I. Vergouwen
Keyword(s):  
Clinical Trial ◽  
Brain Injury ◽  
Subarachnoid Haemorrhage ◽  
Phase Ii ◽  
Intervention Group ◽  
Case Fatality ◽  
Phase Ii Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischemia, poor functional outcome, and case-fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH. Methods A randomized, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously <12 hours, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical- and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case-fatality and inability to obtain CSF, we will include 20 patients per group. Discussion The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH. Trial registration Netherlands Trial Register: NTR6752, https://www.trialregister.nl/trial/6579. Registered on 27 October 2017. European Clinical Trials Database: EudraCT 2017-004307-51.

scholarly journals CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Inez Koopman ◽  
◽  
Gabriel J. E. Rinkel ◽  
Mervyn D. I. Vergouwen
Keyword(s):  
Clinical Trial ◽  
Brain Injury ◽  
Subarachnoid Haemorrhage ◽  
Phase Ii ◽  
Intervention Group ◽  
Case Fatality ◽  
Phase Ii Clinical Trial ◽  
Aneurysmal Subarachnoid Haemorrhage ◽  
Efficacy And Safety ◽  
Randomised Controlled

Abstract Background The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischaemia, poor functional outcome, and case fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve the outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH. Methods A randomised, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case fatality and inability to obtain CSF, we will include 20 patients per group. Discussion The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH. Trial registration Netherlands Trial Register NTR6752. Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51

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