Life Recovery Systems secures IDE to test ThermoSuit cooling device in ischaemic stroke patients

 

All this earlier research was inconclusive. My posts on hypothermia didn't show much benefit so ask your competent? doctor why this one might have better results.

hypothermia (58 posts to February 2011)

Life Recovery Systems secures IDE to test ThermoSuit cooling device in ischaemic stroke patients

Life Recovery Systems (LRS) has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to test its ThermoSuit system (TSS) in a pivotal trial of ischaemic stroke patients.

The US regulator has given IDE approval for the enrolment of a maximum of 160 patients overall in up to eight hospitals. The study will randomise patients to receive standard care either with or without cooling to 32±1°C. Its primary endpoint will be post-stroke cognitive impairment, while secondary endpoints will include neurological recovery and mortality.(Why isn't the endpoint 100% recovery?  You don't believe in measuring what survivors want? That is grounds for firing!

Here is your business101 requirements. Not measuring 100% recovery is the height of incompetence!

“What's measured, improves.” So said management legend and author Peter F. Drucker )

The previous SISCO pilot clinical study—the results of which have been published in Frontiers in Neurology—concluded that the TSS was feasible to use, cooled rapidly and had acceptable safety while also showing trends suggesting improved recovery in ischaemic stroke patients.

“Laboratory studies have predicted that rapid, early cooling would be effective in reducing brain injuries caused by ischaemic strokes, while slow, delayed cooling has failed,” said Robert Schock, vice president of research and development (R&D) at LRS. “Nearly 800,000 Americans suffer strokes each year, and we believe we could help many of them.”

“This is a testament to the unmatched cooling power of the ThermoSuit system,” noted LRS chief executive officer (CEO) Matt Center. “It enhances the investment opportunity in LRS. We are looking forward to pursuing US FDA clearance for the stroke market.”

The TSS uses liquid convection cooling, typically cooling to its target temperature in 40 minutes, according to a recent press release from LRS. The release also states that core temperature is monitored while cooling and, at about 33°C, the water and patient are removed from the suit. The patient is then maintained at target for 24 hours with conventional surface cooling.

LRS further notes that this clinical trial IDE does not represent a final regulatory clearance for an ischaemic stroke indication with the TSS—and that the current US FDA-cleared indications for the device are temperature reduction where clinically indicated, such as in hyperthermic patients, and temperature monitoring.

Conscious sedation no better than general anesthesia in post-stroke endovascular treatment

Both primary and secondary endpoint measures are wrong. The only measurement that survivors care about is 100% recovery. Until we get that mindset installed in stroke researchers we will NEVER SOLVE STROKE.

Conscious sedation no better than general anesthesia in post-stroke endovascular treatment

Conscious sedation was not superior to general anesthesia for functional recovery in patients undergoing endovascular treatment following acute posterior circulation stroke, researchers reported in JAMA Neurology.

Fa Liang, MD, of the department of anesthesiology at Capital Medical University in Beijing, China, and colleagues sought to determine whether conscious sedation was an acceptable alternative to general anesthesia during endovascular treatment in those with acute posterior circulation stroke by conducting a randomized, parallel-group exploratory trial at two comprehensive care hospitals in China.

Source: Adobe Stock.

Of 210 patients with acute posterior circulation stroke admitted from March 2018 to June 2021, 87 (mean age, 62 years; 81.6% men) were included in the final analysis, of whom 43 underwent general anesthesia and 44 conscious sedation. The primary endpoint was functional independence after 90 days.

At baseline, the median participant score on the National Institute of Health Stroke Scale was 15. Thirteen patients (29.5%) in the conscious sedation group were transferred to the general anesthesia group.

The authors reported that although the conscious sedation group had a higher incidence of functional independence, there was no significant difference between the two groups, with analysis indicating that 48.8% of the general anesthesia group had a modified Rankin Score of 0 to 2 at 90 days vs. 54.4% in the conscious sedation group (RR = 0.89; 95% CI, 0.58-1.38 and adjusted OR = 0.91; 95% CI, 0.37-2.22).

However, general anesthesia performed better in successful reperfusion in intention-to-treat analysis (95.3%) compared with conscious sedation (77.3%), according to results (aOR = 5.86; 95% CI, 1.16-29.53).

“[Conscious sedation] was not better than [general anesthesia] for the primary outcome of functional recovery,” the authors wrote. “Moreover, [conscious sedation] was perhaps worse than [general anesthesia] for the secondary outcome of successful reperfusion.”

Diagnosis and Management of Transient Ischemic Attack and Acute Ischemic Stroke

Worse than useless, nothing on 100% recovery, so survivors have to accept the tyranny of low expectations since no one in stroke is even thinking about 100% recovery. 

Diagnosis and Management of Transient Ischemic Attack and Acute Ischemic Stroke

A Review

Scott J. Mendelson, PhD, MD¹; Shyam Prabhakaran, MD, MS^1,2

Author Affiliations

JAMA. 2021;325(11):1088-1098. doi:10.1001/jama.2020.26867

related articles icon

Related

Articles

• JAMA Clinical Guidelines Synopsis
  Management of Patients With Acute Ischemic Stroke
  James R. Brorson, MD; Adam S. Cifu, MD

Abstract

Importance  Stroke is the fifth leading cause of death and a leading cause of disability in the United States, affecting nearly 800 000 individuals annually.

Observations  Sudden neurologic dysfunction caused by focal brain ischemia with imaging evidence of acute infarction defines acute ischemic stroke (AIS), while an ischemic episode with neurologic deficits but without acute infarction defines transient ischemic attack (TIA). An estimated 7.5% to 17.4% of patients with TIA will have a stroke in the next 3 months. Patients presenting with nondisabling AIS or high-risk TIA (defined as a score ≥4 on the age, blood pressure, clinical symptoms, duration, diabetes [ABCD2] instrument; range, 0-7 [7 indicating worst stroke risk]), who do not have severe carotid stenosis or atrial fibrillation, should receive dual antiplatelet therapy with aspirin and clopidigrel within 24 hours of presentation. Subsequently, combined aspirin and clopidigrel for 3 weeks followed by single antiplatelet therapy reduces stroke risk from 7.8% to 5.2% (hazard ratio, 0.66 [95% CI, 0.56-0.77]). Patients with symptomatic carotid stenosis should receive carotid revascularization and single antiplatelet therapy, and those with atrial fibrillation should receive anticoagulation. In patients presenting with AIS and disabling deficits interfering with activities of daily living, intravenous alteplase improves(NOT GOOD ENOUGH!) the likelihood of minimal or no disability by 39% with intravenous recombinant tissue plasminogen activator (IV rtPA) vs 26% with placebo (odds ratio [OR], 1.6 [95% CI, 1.1-2.6]) when administered within 3 hours of presentation and by 35.3% with IV rtPA vs 30.1% with placebo (OR, 1.3 [95% CI, 1.1-1.5]) when administered within 3 to 4.5 hours of presentation. Patients with disabling AIS due to anterior circulation large-vessel occlusions are more likely(NOT GOOD ENOUGH!) to be functionally independent when treated with mechanical thrombectomy within 6 hours of presentation vs medical therapy alone (46.0% vs 26.5%; OR, 2.49 [95% CI, 1.76-3.53]) or when treated within 6 to 24 hours after symptom onset if they have a large ratio of ischemic to infarcted tissue on brain magnetic resonance diffusion or computed tomography perfusion imaging (modified Rankin Scale score 0-2: 53% vs 18%; OR, 4.92 [95% CI, 2.87-8.44]).

Conclusions and Relevance  Dual antiplatelet therapy initiated within 24 hours of symptom onset and continued for 3 weeks reduces stroke risk in select patients with high-risk TIA and minor stroke. For select patients with disabling AIS, thrombolysis within 4.5 hours and mechanical thrombectomy within 24 hours after symptom onset improves functional outcomes.

Diagram that goes with the text, Bad diagram since there are no endpoints showing results. If all I did was show I did processes at work, I 'd be fired in no time.

 

Full Text

New clinical trial to evaluate efficacy of stem cell product in patients disabled with chronic stroke

I see nothing where they are monitoring to see if the stem cells even stayed alive.  Bad research.

http://www.news-medical.net/news/20170516/New-clinical-trial-to-evaluate-efficacy-of-stem-cell-product-in-patients-disabled-with-chronic-stroke.aspx 

Download PDF Copy

May 16, 2017

A clinical trial to evaluate the safety and efficacy of a stem cell product injected directly into the brain to treat chronic motor deficits from ischemic stroke has begun at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth).
McGovern Medical School at UTHealth is the only site in Texas and the central south portion of the country to open enrollment for the multi-institutional, phase 2B study - the first in the U.S. for chronic stroke. Surgeries will be conducted at Memorial Hermann-Texas Medical Center.
"This trial is one of the first randomized, sham-controlled studies to test the efficacy of administering adult-derived stem cells in patients disabled with a chronic stroke," said Sean I. Savitz, M.D., professor and the Frank M. Yatsu Chair in Neurology at McGovern Medical School and director of the UTHealth Institute for Stroke and Cerebrovascular Disease. "We were chosen as one of only a handful of referral centers in the nation and patients from all over the country will be referred to our center for this trial. Overall, the study adds to our growing regenerative medicine program for patients with neurological disorders."

In the double-blind, sham-surgery controlled study, patients randomized to the study intervention will receive a stem cell product made by SanBio and patients must have chronic motor deficits from an ischemic stroke to be eligible for the study. The product, administered through tiny holes bored into the skull and placed near the site of the damage, came from the bone marrow of two healthy adult donors. Enrollment is limited to patients who are between six and 60 months post-stroke and have a chronic motor neurological deficit.
Results of a phase 1/2A study of the stem cell product, presented at the International Society of Stem Cell Research Meeting and published in the journal, Stroke, showed statistically significant improvements in motor function and no safety concerns.
The UTHealth Stroke Program at McGovern Medical School, led by Savitz, is one of the most active research and clinical programs in the country. It was one of the lead sites in the National Institute of Neurological Disease and Stroke's (NINDS) tPA stroke study; was one of eight centers in the country funded by the NIH to conduct specialized translational research to develop novel acute stroke therapies; and receives NINDS fellowship funding to train the next generation of academic leaders in cerebrovascular disease.
The program was the first Comprehensive Stroke Center in the state certified by The Joint Commission and launched the first mobile stroke unit in the country. It has one of the largest telemedicine programs and is affiliated with Memorial Hermann Mischer Neuroscience Institute at the Texas Medical Center.

Source:

https://www.uth.edu/media/story.htm?id=66bb6dcb-0083-4fdf-9507-f0cfa2884e38

Does “Time Is Brain” Also Mean “Time Is Clot”?

Damn, these idiots think that recanalization is the endpoint, it's not,
saving neurons is the endpoint. You damned idiots aren't even solving the right problem.   Solve the neuronal cascade of death.
http://stroke.ahajournals.org/content/45/9/2555.extract?etoc

Time Dependency of Tissue-Type Plasminogen Activator–Induced Recanalization in Acute Ischemic Stroke

1. Georgios Tsivgoulis, MD, PhD, MSc, FESO;
2. Andrei V. Alexandrov, MD

+ Author Affiliations

1. From the Second Department of Neurology, University of Athens, School of Medicine, “Attikon” University Hospital, Athens, Greece (G.T.); Department of Neurology, The University of Tennessee Health Science Center, Memphis (G.T., A.V.A.); and International Clinical Research Center, St. Anne’s University Hospital, Brno, Czech Republic (G.T.).

1. Correspondence to Andrei V. Alexandrov, MD, FAHA, Department of Neurology, The University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163. E-mail avalexandrov@att.net

Key Words:

• Editorial
• reperfusion
• stroke
• ultrasonography, Doppler, transcranial

See related article, p 2734.

Pooled analyses of major randomized controlled trials of intravenous thrombolysis (IVT) in acute ischemic stroke (AIS)^1–3 have established the clinical dictum of “Time is Brain”⁴ because longer times from stroke symptom onset to the initiation of IVT are associated with a lower likelihood of good clinical outcomes at 3 months. Recanalization could be the main mechanism why this time dependency is seen, and the so-called recanalization hypothesis is supported by evidence from a meta-analysis of clinical studies that documented recanalization.⁵ However, no prospective study to date has demonstrated that indeed shorter onset-to-treatment times (OTTs) result in shorter time to recanalization of an intracranial occlusion, in turn proving it to be the key link to better long-term functional outcomes. Conversely, could this also mean that longer times to treatment produce less recanalization attributable to clot maturation and progression of ischemic injury to brain tissues? Could “Time is Brain” also mean “Time is Clot”? As time is lost, clot wins.

In several pilot single-center studies of real-time monitoring of tissue-type plasminogen activator (tPA) infusion by transcranial Doppler (TCD), both the elapsed time from symptom onset to recanalization⁶ and the speed of clot lysis⁷ with IVT thrombolysis were associated with early clinical recovery from AIS as determined by serial National Institutes of Health Stroke Scale assessments. Nevertheless, the effect of the temporal profile of recanalization on 3-month functional outcome after adjusting for potential prognostic factors remains unknown.

In this issue …

[Full Text of this Article]