|
|
|
题名
|
作者
|
年代
|
出处
|
被引量
|
| 1 | Tenecteplase Reperfusion therapy in Acute ischaemic Cerebrovascular Events-Ⅱ (TRACE Ⅱ): rationale and design显示文摘Background and purpose Tenecteplase(TNK)is a promising agent for treatment of acute ischaemic stroke(AIS).We hypothesised that recombinant human TNK tissue-type plasminogen activator(rhTNK-tPA)is non-inferior to rt-PA in achieving excellent functional outcome at 90 days,when administered within 4.5 hours of ischaemic stroke onset.Methods and design Tenecteplase Reperfusion therapy in Acute ischemic Cerebrovascular Events(TRACE)is a phase Ⅲ,multicentre,prospective,randomised,open-label,blinded-end point non-inferiority study.Patients eligible for intravenous thrombolysis therapy are randomised to rhTNK-tPA 0.25 mg/kg(single bolus)to a maximum of 25 mg or rt-PA 0.9 mg/kg(10%bolus+90%infusion/1 hour)to a maximum of 90 mg.Medications considered necessary for the patient’s health may be given at the discretion of the investigator during 90-day follow-up.Study outcomes The primary study outcome is excellent functional outcome defined as modified Rankin Scale(mRS)0–1 at 90 days.Secondary efficacy outcomes include favourable functional outcome defined as mRS≤2 at 90 days,ordinal distribution of mRS and major neurological improvement on the National Institutes of Health Stroke Scale.Safety outcomes are symptomatic intracranial haemorrhage within 36 hours and death from any cause.Discussion There is no completed registration study of TNK in AIS worldwide.TRACE Ⅱ strives to provide evidence for a new drug application for rhTNK-tPA in AIS within 4.5 hours through a well-designed and rigorously executed randomised trial in China. | Shuya Li Bruce C V Campbell Lee H Schwamm Marc Fisher Mark Parsons Hao Li Yuesong Pan Yongjun Wang | 2022 | Stroke & Vascular Neurology2022，7，1： | 2 |
| 2 | Iron and cobalt ethylene polymerization catalys bearing 2,6-bis (imino) pyridyl ligands: synthesis, structures,and polymerization studies 显示文摘 | BRITOVSEK G J P BRUCE M GIBSON V C | 1999 | Journal of American Chemical Society1999，121，38： | 1 |
| 3 | Experimental investigation of melt topology in partially melten quartzo-feldspathic aggregates under hydrostatic and non-hydrostatic stress显示文摘 | Gleason G C Bruce V Green H W | 1999 | Journal of Metamorphic Geology1999，17，： | 1 |
| 4 | Iron and cobalt ethylene polymerization catalysts bearing 2,6-bis(imino) pyridyl ligands:synthesis,structures,and polymerization studies显示文摘 | Bruce M Gibson V C | 1999 | J Am Chem Soc1999，121，： | 1 |
| 5 | A Long-recognized but underappreciated pathological feature of type 2 diabetes 显示文摘 | Steven E K Sofianos A Bruce C V | 1999 | Diabetes1999，48，： | 1 |
| 6 | Cationic Alkyl Aluminium Ethylene Polymerization Catalysts Based on Monoanionic N, N, N-Pyridyliminoamide Ligands 显示文摘 | Bruce M Gibson V C Redshaw C | 1998 | Chem Commun1998，，： | 1 |
| 7 | Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase Ⅱ randomised placebo-controlled double-blind multicentre trial显示文摘Rationale Haematoma 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 design Stopping 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.Hypothesis In patients with spontaneous ICH,treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimates A 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.Intervention Participants 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 measure The 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.Discussion We 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. | Nawaf Yassi Henry Zhao Leonid Churilov Bruce C V Campbell Teddy Wu Henry Ma Andrew Cheung Timothy Kleinig Helen Brown Philip Choi Jiann-Shing Jeng Annemarei Ranta Hao-Kuang Wang Geoffrey C Cloud Rohan Grimley Darshan Shah Neil Spratt Der-Yang Cho Karim Mahawish Lauren Sanders John Worthington Ben Clissold Atte Meretoja Vignan Yogendrakumar Mai Duy Ton Duc Phuc Dang Nguyen Thai My Phuong Huy-Thang Nguyen Chung Y Hsu Gagan Sharma Peter J Mitchell Bernard Yan Mark W Parsons Christopher Levi Geoffrey A Donnan Stephen M Davis | 2022 | Stroke & Vascular Neurology2022，7，2： | 1 |
| 8 | A comparison of productivity and welfare of growing pigs in four intensive systems显示文摘 | Lyons C A P Bruce J M Fowler V R | | 0，，： | 1 |
| 9 | On the significance of transients in daily rhythms显示文摘 | Pittendrigh C S Bruce V G Kaus P | 1958 | PNAS1958，44，9： | 1 |
| 10 | A comparison of productivity and welfare of growing pigs in four intensive systems 显示文摘 | Lyons C A P Bruce J M Fowler V R | 1995 | Livest Prod Sci1995，43，： | 1 |
| 11 | 显示文摘 | Bruce M Gibson V C | 1999 | J Am Chem Soc1999，121，： | 1 |
| 12 | Dynamic analysis of the buckling of laterally loaded flat arches显示文摘 | Hoff N J Bruce V C | 1954 | J Math Phys1954，32，2： | 1 |
| 13 | Endurance training in obese humans improves glucose tolerance and mito- chondrial fatty acid oxidation and alters muscle lipid content 显示文摘 | BRUCE C R THRUSH A B MERTZ V A | 2006 | Am J Physiol Endocrinol Metab2006，291，1： | 1 |
| 14 | Endurance training in obese humans improves glucose tolerance and mito- chondrial fatty acid oxidation and alters muscle lipid content 显示文摘 | BRUCE C R THRUSH A B METZ V A | 2006 | Am J Physiol Endocrinol Metab2006，291，1： | 1 |
| 15 | 显示文摘 | Bruce M Gibson V C | 1999 | J Am Chem Soc1999，121，： | 1 |
| 16 | Iron and cobalt ethylene polymerization catalysts bearing 2,6-bis (imino) pyridyl ligands:Synthesis,structures and polymerization studies显示文摘 | Britovsek G J P Bruce M Gibson V C | 1999 | J Am Chem Soc1999，121，38： | 1 |
| 17 | Cationic alkyl aluminum ethylene polymerization catalysts based on monoanionic N,N,N-pyridyliminoamide ligands显示文摘 | Bruce M Gibson V C Redshaw C | 1998 | ChemCommun1998，，22： | 1 |
| 18 | 查看详情显示文摘 | Britovsek G J P Bruce M Gibson V C Kimberley B S Maddox P J Mastroianni S McTavish S J Redshaw C Solan G A Stromberg S White A J P and Williams D J | | 0，，： | 1 |
| 19 | 查看详情显示文摘 | Bruce M Gibson V C Redshaw C | | 0，，22： | 1 |
| 20 | Dialysis-based bioreactor systems for the production of monoclonal antibodies-alternatives to ascites production in mice显示文摘 | BRUCE M P BOYD V DUCH C | 2002 | J Immunol Methods2002，264，12： | 1 |
您所在的机构暂未开通此部分的功能，请联系管理员