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Efficacy of Early Intensive Blood Pressure Management After Thrombectomy: Protocol for a Randomized Controlled Clinical Trial (IDENTIFY)

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Abstract

Background

The optimal strategy for blood pressure management after thrombectomy remains unknown. The primary objective of The Early Intensive Blood Pressure Management after Endovascular Thrombectomy (IDENTIFY) study is to explore the efficacy and safety of early intensive blood pressure management strategies after thrombectomy compared with that of standard management.

Methods

The IDENTIFY study is a prospective, randomized, open-label, assessor-blinded multicenter clinical trial. Patients with acute anterior circulation ischaemic stroke who underwent endovascular thrombectomy within 6 h of stroke onset, achieved successful recanalization, and had two consecutive blood pressure readings > 130 mm Hg during the first 6 h after thrombectomy will be enrolled and centrally randomized into intensive or standard management groups in a 1:1 ratio. Continuous blood pressure monitoring will be initiated at the end of thrombectomy, and patients with high blood pressure during the transfer to the wards will also be enrolled. For patients in the intensive management group, the target blood pressure will be < 130 mm Hg, and the use of antihypertensive drugs will be discontinued if systolic blood pressure goes below 110 mm Hg. The target blood pressure for the standard management group will be < 180 mm Hg, and if systolic blood pressure decreases below 140 mm Hg, the use of antihypertensive drugs will be stepwise decreased until the systolic blood pressure reaches 140 mm Hg again or the infusion is discontinued. Patients will have their blood pressure reduced to the target range within 1 h from randomization and maintained until 24 h after thrombectomy with intravenous hypertensive drugs. A sample size of 600 was predicted. The primary outcome will be the rate of dependency (modified Rankin Scale scores 3–6) at 90 days. Secondary outcomes will include intracerebral hemorrhage (either symptomatic or asymptomatic) within 24 h and 7 days, malignant brain oedema, all-cause death, death and severe disability at 90 days, and quality of life at 90 days, which will be measured using the EuroQol-5 Dimensions-5 Level (EQ-5D-5L) and the 36-Item Short Form Health Survey (SF-36). Safety outcomes will include stroke recurrence within 24 h, early neurological deterioration, hypotension within 24 h, death within 7 days after endovascular thrombectomy, and all-cause acute kidney injury.

Trial registration chictr.org.cn (identifier: ChiCTR2200057770). Registered March 17, 2022, http://www.chictr.org.cn/edit.aspx?pid=162575&htm=4

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Funding

This research is supported by 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University (No. ZYGD18009) and Sichuan Science and Technology Program (No. 00402053A2038; No. 00402053A29AT).

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Authors and Affiliations

  1. Department of Neurology, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China

    Xuening Zhang, Fayun Hu, Chen Ye, Kun Lu, Ruosu Pan & Bo Wu

  2. Department of Neurology, Centre of Cerebrovascular Disease, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China

    Zilong Hao

  3. Department of Neurology, Minda Hospital of Hubei Minzu University, Enshi, 445000, Hubei, China

    Jincheng Wan

Authors
  1. Xuening Zhang
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  2. Fayun Hu
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  3. Zilong Hao
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  4. Chen Ye
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  5. Jincheng Wan
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  6. Kun Lu
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  7. Ruosu Pan
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  8. Bo Wu
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Contributions

X.Z., F.H., and B.W. were involved in literature reviewing, conceptualization of the research, and protocol development. K.L. and R.P. finished procedures of ethics and registration of this trial. Z.H., B.W., C.Y., and Jincheng Wan made critical revisions of the manuscript for important intellectual content. All authors approved the final version of the manuscript. This manuscript is complied with all instructions to authors.

Corresponding author

Correspondence to Bo Wu.

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Conflicts of interest

There are no conflicts of interest to declare, and the corresponding authors take full responsibility for the protocol, interpretation, the conduct of the research, full access to all of the data, and the right to publish any and all data.

Ethical Approval/Informed Consent

This trial has been approved by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (November 22, 2021, reference: 2021 No.852).

Clinical Trial Registration

This trial has been registered with chictr.org.cn (Identifier: ChiCTR2200057770). The protocol manuscript has not been submitted elsewhere nor published elsewhere in whole or in part.

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Zhang, X., Hu, F., Hao, Z. et al. Efficacy of Early Intensive Blood Pressure Management After Thrombectomy: Protocol for a Randomized Controlled Clinical Trial (IDENTIFY). Neurocrit Care 38, 196–203 (2023). https://doi.org/10.1007/s12028-022-01618-9

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  • DOI: https://doi.org/10.1007/s12028-022-01618-9

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