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The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial

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Ma, Lu, Hu, Xin, Song, Lili, Chen, Xiaoying, Ouyang, Menglu, Billot, Laurent, Li, Qiang, Malavera, Alejandra, Li, Xi, Muñoz-Venturelli, Paula, de Silva, Asita, Thang, Nguyen Huy, Wahab, Kolawole W, Pandian, Jeyaraj D, Wasay, Mohammad, Pontes-Neto, Octavio M, Abanto, Carlos, Arauz, Antonio, Shi, Haiping, Tang, Guanghai, Zhu, Sheng, She, Xiaochun, Liu, Leibo, Sakamoto, Yuki, You, Shoujiang, Han, Qiao, Crutzen, Bernard, Cheung, Emily, Li, Yunke, Wang, Xia, Chen, Chen, Liu, Feifeng, Zhao, Yang, Li, Hao, Liu, Yi, Jiang, Yan, Chen, Lei, Wu, Bo, Liu, Ming, Xu, Jianguo, You, Chao, Anderson, Craig S, Robinson, Thompson, Miranda, J. 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Somaratne, S.D.B, Narayana, Saumya, Gallage, Sithara, Senanayake, Bimsara, Samarasiri, Udari, Luke, Dunya, Sivapathasundaram, Mythily, Sahadevan, Vithoosan, Rasmi, Amani, Deshaka, Yuran, Fernando, Nilukshi, Munasinghe, Aruna, Rathnapriya, Kapilanga, Nissanka, A.S, Karunathilake, Kanchana, Gayan, Isuru, Wijenayake, Kaminda, Gunasekara, Hasitha, Vidyarathne, Jagath, Keshavaraj, Ajantha, Janarthanan, Kanagasabapathy, Gerald Jeevathasan, Arhivalaky, Sivamainthan, Sivaram, John Priyanth, Mathyamuthan, John Priyanth, Abirami, Rajendiran, Thambippillai, Alwis, Sanjeewa, Gunasekare, Nushara, Liyanarachchi, Vasundara, Dissanayake, Athula, Uluwattage, Wimalasiri Mewa, Ratnayake, Gimhani, Rajinee, Charika, Jayawardana, Sakura, Peiris, Janaka, Wicramasinghe, Ranjith, Fernando, Chamila, Abbas, Jessie, Withanage, Nethmini, Bandara, Makaranda, Mai, Duy Ton, Nguyen, Van Chi, Dao, Viet Phuong, Vuong, Xuan Trung, Nguyen, Tien Dung, Dinh, Trung Hieu, Phan, Ha Quan, Bui, Quoc Viet, Phung, Dinh Tho, Pham, Quang Tho, Pham, Dinh Dai, Do, Duc Thuan, Dang, Phuc Duc, Dang, Minh Duc, Nguyen, Dang Hai, Nguyen, Thi Phuong Nga, Nguyen, Quoc Huy, Pham, Quoc Dai, Chau, Quoc Vinh, Tai, Vinh Thy Van, Le, Tran Vinh, Le, Cong Tri, Tran, Ha Mai Khuong, Nguyen, Huu Khanh, Ngyen, Hoang Minh Thao, Vo, Duc Chien, Nguyen, Thai My Phuong, Tran, Trung Thanh, Vo, Thi Hanh Vi, Cao, Hao Nhien, Nguyen, Ba Thang, Le, Thi Ngoc Suong, La, Thien Duc, Pham, Chi Duc, Thai, Huy·2023·The Lancet
DOI 10.1016/s0140-6736(23)00806-1
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Abstract

BACKGROUND: Early control of elevated blood pressure is the most promising treatment for acute intracerebral haemorrhage. We aimed to establish whether implementing a goal-directed care bundle incorporating protocols for early intensive blood pressure lowering and management algorithms for hyperglycaemia, pyrexia, and abnormal anticoagulation, implemented in a hospital setting, could improve outcomes for patients with acute spontaneous intracerebral haemorrhage. METHODS: We performed a pragmatic, international, multicentre, blinded endpoint, stepped wedge cluster randomised controlled trial at hospitals in nine low-income and middle-income countries (Brazil, China, India, Mexico, Nigeria, Pakistan, Peru, Sri Lanka, and Viet Nam) and one high-income country (Chile). Hospitals were eligible if they had no or inconsistent relevant, disease-specific protocols, and were willing to implement the care bundle to consecutive patients (aged ≥18 years) with imaging-confirmed spontaneous intracerebral haemorrhage presenting within 6 h of the onset of symptoms, had a local champion, and could provide the required study data. Hospitals were centrally randomly allocated using permuted blocks to three sequences of implementation, stratified by country and the projected number of patients to be recruited over the 12 months of the study period. These sequences had four periods that dictated the order in which the hospitals were to switch from the control usual care procedure to the intervention implementation of the care bundle procedure to different clusters of patients in a stepped manner. To avoid contamination, details of the intervention, sequence, and allocation periods were concealed from sites until they had completed the usual care control periods. The care bundle protocol included the early intensive lowering of systolic blood pressure (target <140 mm Hg), strict glucose control (target 6·1-7·8 mmol/L in those without diabetes and 7·8-10·0 mmol/L in those with diabetes), antipyrexia treatment (target body temperature ≤37·5°C), and rapid reversal of warfarin-related anticoagulation (target international normalised ratio <1·5) within 1 h of treatment, in patients where these variables were abnormal. Analyses were performed according to a modified intention-to-treat population with available outcome data (ie, excluding sites that withdrew during the study). The primary outcome was functional recovery, measured with the modified Rankin scale (mRS; range 0 [no symptoms] to 6 [death]) at 6 months by masked research staff, analysed using proportional ordinal logistic regression to assess the distribution in scores on the mRS, with adjustments for cluster (hospital site), group assignment of cluster per period, and time (6-month periods from Dec 12, 2017). This trial is registered at Clinicaltrials.gov (NCT03209258) and the Chinese Clinical Trial Registry (ChiCTR-IOC-17011787) and is completed. FINDINGS: Between May 27, 2017, and July 8, 2021, 206 hospitals were assessed for eligibility, of which 144 hospitals in ten countries agreed to join and were randomly assigned in the trial, but 22 hospitals withdrew before starting to enrol patients and another hospital was withdrawn and their data on enrolled patients was deleted because regulatory approval was not obtained. Between Dec 12, 2017, and Dec 31, 2021, 10 857 patients were screened but 3821 were excluded. Overall, the modified intention-to-treat population included 7036 patients enrolled at 121 hospitals, with 3221 assigned to the care bundle group and 3815 to the usual care group, with primary outcome data available in 2892 patients in the care bundle group and 3363 patients in the usual care group. The likelihood of a poor functional outcome was lower in the care bundle group (common odds ratio 0·86; 95% CI 0·76-0·97; p=0·015). The favourable shift in mRS scores in the care bundle group was generally consistent across a range of sensitivity analyses that included additional adjustments for country and patient variables (0·84; 0·73-0·97; p=0·017), and with different approaches to the use of multiple imputations for missing data. Patients in the care bundle group had fewer serious adverse events than those in the usual care group (16·0% vs 20·1%; p=0·0098). INTERPRETATION: Implementation of a care bundle protocol for intensive blood pressure lowering and other management algorithms for physiological control within several hours of the onset of symptoms resulted in improved functional outcome for patients with acute intracerebral haemorrhage. Hospitals should incorporate this approach into clinical practice as part of active management for this serious condition. FUNDING: Joint Global Health Trials scheme from the Department of Health and Social Care, the Foreign, Commonwealth & Development Office, and the Medical Research Council and Wellcome Trust; West China Hospital; the National Health and Medical Research Council of Australia; Sichuan Credit Pharmaceutic and Taked

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Ma, L., Hu, X., Song, L., Chen, X., Ouyang, M., Billot, L., Li, Q., Malavera, A., Li, X., Muñoz-Venturelli, P., de Silva, A., Thang, N. H., Wahab, K. W., Pandian, J. D., Wasay, M., Pontes-Neto, O. M., Abanto, C., Arauz, A., Shi, H., Tang, G., Zhu, S., She, X., Liu, L., Sakamoto, Y., You, S., Han, Q., Crutzen, B., Cheung, E., Li, Y., Wang, X., Chen, C., Liu, F., Zhao, Y., Li, H., Liu, Y., Jiang, Y., Chen, L., Wu, B., Liu, M., Xu, J., You, C., Anderson, C. S., Robinson, T., Miranda, J. J., Anderson, C. 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Venue
The Lancet
Publisher
Elsevier BV
Published
2023-07
Volume
402
Issue
10395
Pages
27-40
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(23)00806-1
OpenAlex
W4378219880
Cited by
407
References
4
FWCI
59.47
Type
journal article
Language
en
Open access
hybrid

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.