The Spot Sign and Tranexamic Acid on Preventing ICH Growth – AUStralasia Trial (STOP-AUST): Protocol of a Phase II Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial

2013 ◽  
Vol 9 (4) ◽  
pp. 519-524 ◽  
Author(s):  
Atte Meretoja ◽  
Leonid Churilov ◽  
Bruce C. V. Campbell ◽  
Richard I. Aviv ◽  
Nawaf Yassi ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Phase Ii ◽  
Multicenter Trial ◽  
Spot Sign ◽  
Double Blind

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

Administration of DAB389IL-2 to patients with recalcitrant psoriasis: A double-blind, phase II multicenter trial

1998 ◽  
Vol 38 (6) ◽  
pp. 938-944 ◽  
Author(s):  
Jerry Bagel ◽  
W.Thomas Garland ◽  
Debra Breneman ◽  
Michael Holick ◽  
T.W. Littlejohn ◽  
...  
Keyword(s):  
Phase Ii ◽  
Multicenter Trial ◽  
Double Blind

Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design

2017 ◽  
Vol 12 (3) ◽  
pp. 326-331 ◽  
Author(s):  
Liping Liu ◽  
Yilong Wang ◽  
Xia Meng ◽  
Na Li ◽  
Ying Tan ◽  
...  
Keyword(s):  
High Risk ◽  
Intracerebral Hemorrhage ◽  
Tranexamic Acid ◽  
Primary Outcome Measure ◽  
Hematoma Expansion ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Patients ◽  
Acute Intracerebral Hemorrhage ◽  
Hemorrhage Volume

Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8 h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.

scholarly journals STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease

2020 ◽  
pp. jrheum.191365
Author(s):  
Dinesh Khanna ◽  
Donald P. Tashkin ◽  
Athol U. Wells ◽  
James R. Seibold ◽  
Stephen Wax ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Multicenter Trial ◽  
Rate Of Change ◽  
Double Blind ◽  
Parallel Group ◽  
To Receive

Objective To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). Methods STRATUS was a Phase II, double-blind, parallel-group, multicenter trial (NCT02745145). Adults (≤75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. Results STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized), precluding robust analysis of efficacy. Abituzumab was well-tolerated; no new safety signals were detected. Conclusion Further investigation of abituzumab for treatment of SSc-ILD is required.

Efficacy and Safety of Mildronate for Acute Ischemic Stroke: A Randomized, Double-Blind, Active-Controlled Phase II Multicenter Trial

2013 ◽  
Vol 33 (10) ◽  
pp. 755-760 ◽  
Author(s):  
Yi Zhu ◽  
Guangyun Zhang ◽  
Jun Zhao ◽  
Deshuai Li ◽  
Xiaodong Yan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Phase Ii ◽  
Multicenter Trial ◽  
Efficacy And Safety ◽  
Double Blind

scholarly journals Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

2021 ◽  
pp. svn-2021-001070
Author(s):  
Nawaf Yassi ◽  
Henry Zhao ◽  
Leonid Churilov ◽  
Bruce C V Campbell ◽  
Teddy Wu ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Sample Size ◽  
Phase Ii ◽  
Intracerebral Haemorrhage ◽  
Absolute Difference ◽  
Primary Efficacy ◽  
Double Blind ◽  
Stroke Units ◽  
Primary Efficacy Measure ◽  
Efficacy Measure

RationaleHaematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth.Methods and designStopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework.HypothesisIn patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimatesA sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.InterventionParticipants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo.Primary efficacy measureThe primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.DiscussionWe describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.

scholarly journals A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Trial of Endostar in Patients With Metastatic Melanoma

2013 ◽  
Vol 21 (7) ◽  
pp. 1456-1463 ◽  
Author(s):  
Chuanliang Cui ◽  
Lili Mao ◽  
Zhihong Chi ◽  
Lu Si ◽  
Xinan Sheng ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Phase Ii ◽  
Multicenter Trial ◽  
Double Blind ◽  
Double Blind Placebo
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