Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol.

IF 6.3 2区医学 Q1 CLINICAL NEUROLOGY International Journal of Stroke Pub Date : 2025-01-03 DOI:10.1177/17474930241307933

Jeyaraj Durai Pandian, Atul Phillips, Shweta Jain Verma, Deepti Arora, Aneesh Dhasan, Pheba S Raju, P N Sylaja, Biman Kanti Ray, Uddalak Chakraborty, Jacob Johnson, Praveen Kumar Sharma, Sanjeev Bhoi, Menka Jha, Thomas Iype, Chithra P, Dheeraj Khurana, Sucharita Ray, Dwijen Das, Naurima Kalita, Sweekriti Adhikari, Ashish Sharma, Jayanta Roy, Rajeshwar Sahonta, Sulena Singh, Vikram Chaudhary, Girish Menon, Sanjith Aaron, Deepti Bal, Rajinder K Dhamija, Monali Chaturvedi, Siddarth Maheshwari, Aralikatte Onkarappa Saroja, Karkal R Naik, Neeraj Bhutani, Kailash Dhankhar, Dinesh Sharma, Rohit Bhatia, Sankar Prasad Gorthi, Binod Sarmah, Vijaya Pamidimukkala, Sankaralingam Saravanan, Sunil Narayan, Lakshya J Basumatary, Nagarjunakonda V Sundarachary, Aruna K Upputuri, Ummer Karadan, V G Pradeep Kumar, Rajsrinivas Parthasarathy, Darshan Doshi, Satish Wagh, Tcr Ramakrishnan, Saleem Akhtar, Soaham Desai, N C Borah, Rupjyoti Das, Gaurav Mittal, Agam Jain, Paul J Alapatt, Girish Baburao Kulkarni, Deepak Menon, Pritam Raja, Inder Puri, Vivek Nambiar, Muralidhar Reddy Yerasu, Shyam K Jaiswal, Kapil Zirpe, Sushma Gurav, Sudheer Sharma, S Kumaravelu, Rajesh Benny, Vicky Thakkar, Abhishek Pathak, Madhusudhan Kempegowda, Praveen Chander, Neetu Ramrakhiani, Arya Devi Ks, P Sankara Sarma, Rahul Huilgol, Meenakshi Sharma, Rupinder S Dhaliwal

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Abstract

Rationale: Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious.

Hypothesis: Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days.

Design: Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90.

Summary: If proven to be beneficial, TXA will have a major impact on medical management of ICH.

Trial registration: Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).

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氨甲环酸在自发性脑出血中的印度试验（内在试验）研究方案。

理由：脑出血（ICH）的早期死亡是由于血肿体积（HV）扩大，除了降低血压之外没有有效的治疗方法。氨甲环酸（TXA）是一种广泛可用且安全的止血药物，如果证明有效，可以成为一种具有成本效益的脑出血治疗方法。假设：脑出血患者在症状出现后4.5小时内给予TXA可降低30天的早期死亡率。设计：氨甲环酸治疗自发性脑出血的印度试验（INTRINSIC试验）是一项多中心、随机、开放标签的试验，纳入年龄在18岁以上、在症状出现4.5小时内或最后一次见到时出现非外伤性脑出血的患者。研究参与者在45分钟内服用2克TXA，而对照组则接受标准治疗。两组患者均按照INTERACT 2方案进行强化降压。研究计划招募3400名患者。主要结局是第30天的死亡率。次要结果是放射学上的HV在24小时内较基线降低，在第7天或更早（如果出院）时出现神经损伤，以及在第90天对依赖性和生活质量进行评估。总结：如果证实是有益的，TXA将对ICH的医疗管理产生重大影响。试验注册：印度临床试验注册中心（CTRI/2023/03/050224）和临床试验。gov （NCT05836831）。

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来源期刊

International Journal of Stroke 医学-外周血管病

CiteScore

13.90

自引率

6.00%

发文量

132

审稿时长

6-12 weeks

期刊介绍： The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.