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Ischemic StrokeRESCUE-HYPONCT05676957

Reperfusion With Hypothermia in Acute Ischemic Stroke

A study testing Thermogard XP3 in people with Ischemic Stroke and Revascularization, run by Liping Liu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Thermogard XP3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Mar 2023to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

Man Li contact

13141410249

lemmon_20@163.com

About this study

Official title: A Prospective, Randomized-controlled Trial to Assess the Safety and Efficacy of Intravascular Hypothermia in Acute Ischemia Stroke Patients With Recanalization After Thrombectomy

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.

Read the detailed description

Hypothermia has been confirmed and widely applied in the treatment of coma patients after resuscitation from cardiac arrest, but its effect on the prognosis of patients with AIS is still controversial. Previous basic research has confirmed that hypothermia can significantly reduce the infarct volume and improve the survival rate and behavioral defects of mice by protecting ischemic brain tissue and improving reperfusion injury through a variety of ways. Therefore, we hypothesized that hypothermia can improve the prognosis of patients with AIS after reperfusion by improving reperfusion injury. This is a phase II clinical trial to to verify the efficacy and safety of endovascular hypothermia in these patients,This study enrolled patients with massive cerebral infarction after endovascular treatment recanalization, patients are divided into study group and control group. The study group received endovascular hypothermia for 12 hours following endovascular treatment and recanalization, and the control group received only usual medical treatment following endovascular treatment and recanalization. We will preliminarily explore the mechanism of endovascular hypothermia in successful reperfusion of large vessel occlusion AIS, and to provide reference for the design of future clinical trials.

Being tested
Thermogard XP3
Keywords
Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
Medical subject headings
Ischemic Stroke, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermogard XP3Device

    Also called intravascular hypothermia treatment

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

Study groups in NCT05676957
Study groupRoleWhat they receive
Study groupExperimentalThe 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.
Receives: Device: Thermogard XP3
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hour after thrombectomy

  2. 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.

    Measured: three to seven days after endovascular therapy

Secondary outcomes (4)

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

    Compare the rate of 90-day mRS (0-2) between study group and control group

    Measured: 90 days

  2. The rate of early neurological deterioration

    increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization

    Measured: 24 hours

  3. The rate of mortality

    The rate of mortality

    Measured: 90 days

  4. Systematic Intracranial Hemorrhagr(sICH)

    sICH with 24 ±3h post recanalization

    Measured: 24 ±3hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676957
Sponsor's protocol ID
RESCUE-HYPO
Acronym
RESCUE-HYPO
Status last verified
Jan 2023
First submitted
3 Jan 2023
Last updated
11 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31662037

  • 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.

    PubMed 26898852

  • 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.

    PubMed 11856793

  • 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.

    PubMed 33681741

  • 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.

    PubMed 29896428

  • 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.

    PubMed 17478443

  • 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.

    PubMed 26696645

  • 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.

    PubMed 20724711

  • 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.

    PubMed 27834742

  • 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.

    PubMed 22064429

  • 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.

    PubMed 30019993

  • 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.

    PubMed 23468538

  • 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.

    PubMed 24203846

Questions about this trial

What is this clinical trial studying?

A study testing Thermogard XP3 in people with Ischemic Stroke and Revascularization, run by Liping Liu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Man Li (13141410249, lemmon_20@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization. (time frame: 2 hour after thrombectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05676957, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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