Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC TRIAL) Study Protocol.

IF 6.3 2区医学 Q1 CLINICAL NEUROLOGY

International Journal of Stroke Pub Date : 2024-12-05 DOI:10.1177/17474930241307933

Jeyaraj Durai Pandian, Atul Phillips, Shweta J 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 Dhamija, Monali Chaturvedi, Siddharth 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, Madhusudan B Kempegowda, Praveen Chander, Neetu Ramrakhiani, Arya Devi Ks, P Sankara Sarma, Rahul Huilgol, Meenakshi Sharma, Rupinder S Dhaliwal

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引用次数: 0

Abstract

Rationale: Early mortality in intracerebral haemorrhage (ICH) is due to haematoma volume (HV) expansion and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug which 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 hours 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 hours of symptom onset or when last seen well. Study participants receive 2 grams of TXA administered within 45 minutes while control group receives standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed in done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction of HV at 24 hours 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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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.