Reperfusion With Hypothermia in Acute Ischemic Stroke

NCT05676957 | Unknown

• 1 other identifier: RESCUE-HYPO
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine the feasibility and safety of receiving intravascular hypothermia treatment for patients experiencing endovascular treatment after acute ischemic stroke(AIS) due to a large vessel occlusion.

Conditions

Ischemic Stroke; Revascularization; Endovascular Treatment; Reperfusion Injury

Keywords

Ischemic Stroke; Revascularization; Endovascular Treatment; Reperfusion Injury

Outcome Measures

Primary Outcomes (2)

• Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.

  Percentage of study group patients achieving target temperature \< 34 ºC within 2 hour after recanalization.

  2 hour after thrombectomy

• final infarct volume（FIV）

  Infarct volume was assessed according to the non-contrast Computed Tomography (NCCT) 3-7 days after surgery, and if several NCCT examinations were performed within 3-7 days, the last CT was used.

  three to seven days after endovascular therapy

Secondary Outcomes (4)

• the rate of 90-day modified Rankin Scale (mRS)(0-2)

  90 days

• The rate of early neurological deterioration

  24 hours

• The rate of mortality

  90 days

• Systematic Intracranial Hemorrhagr(sICH)

  24 ±3hours

Study Arms (2)

Study group

EXPERIMENTAL

The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.

Device: Thermogard XP3

Control group

NO INTERVENTION

The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.

Interventions

Thermogard XP3 DEVICE

Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization.

Also known as: intravascular hypothermia treatment

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years;
• Patients with symptoms consistent with an AIS;
• Pre-stroke mRS score 0-1;
• NIHSS score 6-30 at the time of randomization;
• Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography(MRA) proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
• Imaging showed massive infarction: within 24h of onset and Alberta Stroke Program Early CT Score (ASPECTS) \< 3, and large infarct core 70-100 ml (CT perfusion \[ Relative Cerebral Blood Flow (rCBF) \< 30%\]); within 24h of onset and ASPCECTS score 3-5 (based on NCCT); ASPECTS \> 5, within 6h-24h of onset,and large infarct core 70-100 ml (CTP \[rCBF \< 30%\]);
• Successful recanalization of occluded vessel (modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3) after EVT;
• Patients and/or their families agreed to enter the trial.

You may not qualify if:

• CT after reperfusion showed PH2 hemorrhagic transformation;
• bilateral stroke or multiple intracranial occlusions;
• known presence of Inferior Vena Cava (IVC) filter;
• end-stage renal disease on hemodialysis;
• known hemorrhagic diathesis, coagulation factor deficiency or platelet count \< 5 × 109/L, International Normalized Ratio(INR) \> 1.7;
• known hypersensitivity to meperidine, buspirone, midazolam and other sedative and analgesic drugs;
• pregnant women;
• combined malignant tumors, sepsis, hypothyroidism;
• unstable vital signs/dying state, requiring vasoactive drugs to maintain hemodynamic stability and in the incremental phase;
• cardiac function grade 4/severe liver and kidney dysfunction;
• has participated in other drugs or device clinical trials that may have an impact on the current study;
• other reasons lead the investigator to believe that patients are not suitable to continue hypothermia treatment.

Sponsors & Collaborators

• Liping Liu: lead

Related Publications (13)

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

  PMID: 31662037 BACKGROUND

• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

  PMID: 26898852 BACKGROUND

• Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

  PMID: 11856793 BACKGROUND

• Hui J, Feng J, Tu Y, Zhang W, Zhong C, Liu M, Wang Y, Long L, Chen L, Liu J, Mou C, Qiu B, Huang X, Huang Q, Zhang N, Yang X, Yang C, Li L, Ma R, Wu X, Lei J, Jiang Y, Liu L, Gao G, Jiang J; LTH-1 Trial collaborators. Safety and efficacy of long-term mild hypothermia for severe traumatic brain injury with refractory intracranial hypertension (LTH-1): A multicenter randomized controlled trial. EClinicalMedicine. 2021 Jan 28;32:100732. doi: 10.1016/j.eclinm.2021.100732. eCollection 2021 Feb.

  PMID: 33681741 BACKGROUND

• Liu X, Wen S, Zhao S, Yan F, Zhao S, Wu D, Ji X. Mild Therapeutic Hypothermia Protects the Brain from Ischemia/Reperfusion Injury through Upregulation of iASPP. Aging Dis. 2018 Jun 1;9(3):401-411. doi: 10.14336/AD.2017.0703. eCollection 2018 Jun.

  PMID: 29896428 BACKGROUND

• van der Worp HB, Sena ES, Donnan GA, Howells DW, Macleod MR. Hypothermia in animal models of acute ischaemic stroke: a systematic review and meta-analysis. Brain. 2007 Dec;130(Pt 12):3063-74. doi: 10.1093/brain/awm083. Epub 2007 May 3.

  PMID: 17478443 BACKGROUND

• Su Y, Fan L, Zhang Y, Zhang Y, Ye H, Gao D, Chen W, Liu G. Improved Neurological Outcome With Mild Hypothermia in Surviving Patients With Massive Cerebral Hemispheric Infarction. Stroke. 2016 Feb;47(2):457-63. doi: 10.1161/STROKEAHA.115.009789. Epub 2015 Dec 22.

  PMID: 26696645 BACKGROUND

• Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.

  PMID: 20724711 BACKGROUND

• Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.

  PMID: 27834742 BACKGROUND

• Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.

  PMID: 22064429 BACKGROUND

• Wu C, Zhao W, An H, Wu L, Chen J, Hussain M, Ding Y, Li C, Wei W, Duan J, Wang C, Yang Q, Wu D, Liu L, Ji X. Safety, feasibility, and potential efficacy of intraarterial selective cooling infusion for stroke patients treated with mechanical thrombectomy. J Cereb Blood Flow Metab. 2018 Dec;38(12):2251-2260. doi: 10.1177/0271678X18790139. Epub 2018 Jul 18.

  PMID: 30019993 BACKGROUND

• Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.

  PMID: 23468538 BACKGROUND

• Hong JM, Lee JS, Song HJ, Jeong HS, Choi HA, Lee K. Therapeutic hypothermia after recanalization in patients with acute ischemic stroke. Stroke. 2014 Jan;45(1):134-40. doi: 10.1161/STROKEAHA.113.003143. Epub 2013 Nov 7.

  PMID: 24203846 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Reperfusion Injury

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liping Liu

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Li

CONTACT

13141410249; lemmon_20@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 9, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share