HI-SPEED Protocol for Stroke

(HI-SPEED Trial)

Recruiting at 6 trial locations

Overseen By Jane L Holl, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: TIA, Stroke NOS, Comfort care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how hospitals quickly evaluate and transfer stroke patients needing advanced care. It focuses on expediting the "Door-In-Door-Out" process, known as the HI-SPEED Protocol, to ensure timely treatment. The study will test new methods in hospitals across the US to accelerate these transfers. Individuals diagnosed with a type of stroke, such as a brain bleed or blockage, and requiring quick evaluation may find this trial relevant. As an unphased trial, it offers a unique opportunity to contribute to advancements in stroke care and potentially benefit from faster treatment protocols.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for stroke patients?

Research shows that the HI-SPEED Protocol for stroke is generally safe. Studies have found that when guidelines are carefully followed, major safety issues, such as bleeding in the brain, do not occur. This indicates that patients usually tolerate the treatment well. The main goal of this protocol is to quickly and effectively transport stroke patients to hospitals for advanced care. Although specific negative side effects are not mentioned, the absence of major safety concerns is encouraging for prospective clinical trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HI-SPEED Protocol for stroke because it aims to revolutionize stroke care by speeding up treatment delivery times. Unlike traditional methods, which often involve multiple steps and can be slow, this protocol streamlines emergency response processes to reduce the time between symptom onset and treatment. By potentially cutting down these critical minutes, the HI-SPEED Protocol could significantly improve patient outcomes and reduce long-term disability. This innovative approach focuses on enhancing the efficiency and coordination of stroke care, which could set a new standard for emergency medical responses.

What evidence suggests that the HI-SPEED Protocol is effective for improving stroke patient transfers?

Research shows that the HI-SPEED Protocol, which participants in this trial will experience during the Implementation Phase, can help stroke patients receive advanced care more quickly. Studies have found that reducing "Door-In-Door-Out" (DIDO) time, the period from patient admission to treatment, leads to better recovery outcomes. By accelerating the process from hospital admission to treatment, patients have a better chance of recovering. Specifically, one study found that a streamlined protocol like HI-SPEED reduced the time needed to restore blood flow, crucial for treating strokes. This evidence supports the effectiveness of the HI-SPEED Protocol in improving stroke care and outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Shyam Prabhakaran, MD, MS

Principal Investigator

University of Chicago

Jane Holl, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have been diagnosed with a stroke, specifically Acute Ischemic Stroke (AIS), Intracerebral Hemorrhage (ICH), or Subarachnoid Hemorrhage (SAH). It's designed to help hospitals improve the speed and efficiency of transferring stroke patients to advanced care facilities.

Inclusion Criteria

My final diagnosis is a stroke or brain hemorrhage.

Exclusion Criteria

I have been diagnosed with a stroke or TIA.

Left hospital against medical advice

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Pre-implementation of HI-SPEED Protocol to establish baseline DIDO times

Duration not specified

Implementation Phase

Post-Implementation of HI-SPEED Protocol to evaluate its effectiveness in reducing DIDO times

Duration not specified

Follow-up

Participants are monitored for functional outcomes using the Modified Rankin Scale at 3 months post-stroke

3 months

What Are the Treatments Tested in This Trial?

Interventions

• HI-SPEED Protocol

Trial Overview

The HI-SPEED Protocol is being tested in this study. This protocol aims to streamline the process for evaluating stroke patients quickly at local hospitals and determining if they need to be transferred rapidly to specialized centers for advanced treatments.

How Is the Trial Designed?

Group I: Implementation Phase Active Control 1 Intervention

Post-Implementation of HI-SPEED Protocol

Group II: Control Phase Active Control 1 Intervention

Pre-implementation of HI-SPEED Protocol

HI-SPEED Protocol is already approved in United States for the following indications:

Approved in United States as HI-SPEED Protocol for:

• Stroke evaluation and disposition
• Emergency stroke care

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A streamlined protocol for managing acute ischemic stroke patients significantly reduced the time from hospital admission to reperfusion, which is crucial for improving patient outcomes.

The interdisciplinary standard operating procedure (SOP) involved collaboration among stroke neurologists, neuroradiologists, and anesthesiologists, leading to better efficiency and enhanced clinical outcomes for patients undergoing endovascular treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized Management of Endovascular Treatment for Acute Ischemic Stroke. Schregel, K., Behme, D., Tsogkas, I., et al.[2018]

In a systematic review of 9 studies involving 66,675 patients, dual antiplatelet pretreatment (DAPP) was initially linked to a higher risk of symptomatic intracranial hemorrhage (sICH) and increased 3-month mortality, suggesting potential safety concerns.

However, after adjusting for confounding factors, DAPP did not show a significant association with adverse outcomes, indicating that it may not increase the risk of complications in patients with acute ischemic stroke treated with intravenous thrombolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of dual antiplatelet pretreatment in patients with ischemic stroke treated with IV thrombolysis: A systematic review and meta-analysis. Malhotra, K., Katsanos, AH., Goyal, N., et al.[2021]

In a study of 511 patients with large vessel occlusion stroke, the average door-in-door-out (DIDO) time was 137.8 minutes, highlighting the need for timely transfers to endovascular stroke centers for effective treatment.

Factors such as vascular imaging and treatment at non-certified stroke centers significantly increased DIDO times, suggesting that improving imaging workflows and transferring patients from certified centers could enhance the efficiency of stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with door-in-door-out times in large vessel occlusion stroke patients undergoing endovascular therapy. Kuc, A., Isenberg, DL., Kraus, CK., et al.[2023]

In a study of 62 patients transferred for endovascular clot retrieval (ECR) in a rural telestroke network, the median time from rural hospital to comprehensive stroke center was 308 minutes, with a significant portion of that time (68%) spent at the rural hospitals.

Air transfers for ECR took longer than road transfers, primarily due to extended decision-making times, highlighting the need for improved systems to optimize transfer processes and decision support for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Air vs. Road Decision for Endovascular Clot Retrieval in a Rural Telestroke Network. Gangadharan, S., Lillicrap, T., Miteff, F., et al.[2020]

In a study of 743 patients treated with intravenous thrombolysis for ischemic stroke in Belgium, the treatment was found to be safe and effective, with no significant increase in symptomatic intracerebral hemorrhage compared to non-Belgian patients.

Despite the treatment's safety, Belgian patients showed a slightly higher mortality rate at 3 months, which was not linked to an increased risk of bleeding, suggesting other factors may contribute to this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Belgian experience with intravenous thrombolysis for acute ischemic stroke. Vanacker, P., Thijs, V., Peeters, A., et al.[2022]

A large study involving 56,258 patients across 793 centers found that off-label intravenous thrombolysis (IVT) for acute ischemic stroke is generally safe, particularly for patients with minor strokes, as they showed a lower risk of symptomatic intracranial hemorrhage (SICH).

However, patients with high blood pressure were identified as at higher risk for SICH, indicating that careful individual risk-benefit assessments are necessary when considering off-label IVT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of symptomatic intracranial haemorrhage in off-label thrombolysis: an analysis of the Safe Implementation of Treatments in Stroke registry. Mundiyanapurath, S., Hees, K., Ahmed, N., et al.[2019]

The implementation of an AutoLaunch protocol for transferring stroke patients significantly reduced the door-in to door-out (DIDO) time, with a median time of 85 minutes compared to 109 minutes for traditional dispatch methods, based on a study of 92 interfacility transfers.

This reduction in DIDO time suggests that the AutoLaunch protocol may improve the efficiency of care for patients with large vessel occlusion (LVO) strokes, potentially leading to better outcomes, although further studies are needed to assess the impact on patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Door-In to Door-Out Time for Patients Receiving a Mechanical Thrombectomy Using AutoLaunch Protocol. Howell, DM., Li, T., Quellhorst, E., et al.[2023]

Only 11% of the 14,821 STEMI patients studied had a door-in to door-out (DIDO) time of 30 minutes or less, which is recommended to expedite treatment, but those who did were significantly more likely to have overall door-to-balloon (DTB) times of 90 minutes or less (60% vs 13%).

Patients with DIDO times greater than 30 minutes had a higher in-hospital mortality rate (5.9%) compared to those with DIDO times of 30 minutes or less (2.7%), indicating that quicker transfer times are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of door-in to door-out time with reperfusion delays and outcomes among patients transferred for primary percutaneous coronary intervention. Wang, TY., Nallamothu, BK., Krumholz, HM., et al.[2016]

Thrombolytic therapy has been effectively administered in a basic hospital setting for ischemic stroke, with four cases treated over three years following a strict protocol from the NINDS rt-PA stroke study.

The treatment was found to be safe, as there were no instances of intracranial hemorrhage or protocol violations, demonstrating the protocol's reliability in managing stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thrombolysis in acute ischemic stroke in basic hospitals. four cases reports]. Varela, A., de Rojas, P., Vegas, R., et al.[2016]

In a study of 93 patients transferred from STEMI referral hospitals to receiving centers, only 24% of transfers met the recommended 'door-in-door-out' (DIDO) time of 30 minutes, indicating significant challenges in achieving this goal.

While the use of system-wide quality improvement programs was linked to shorter DIDO times, the overall implementation of critical practices did not show a direct association with reduced DIDO times, suggesting that more targeted strategies are needed to enhance efficiency in STEMI care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Hospital Practices and Door-in-door-out Time in ST-segment Elevation Myocardial Infarction. Mumma, BE., Eggert, J., Mahler, SA., et al.[2018]

In a study of 337 patients with acute ischemic stroke, various causes of delay in administering reperfusion therapy were identified, highlighting the importance of timely treatment for better outcomes.

Modifiable factors contributing to delays included variability in following established protocols and the absence of procedures in certain areas of the stroke-care process, indicating areas for future quality improvement initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Why is reperfusion therapy delayed in stroke code patients? A qualitative analysis]. Palazón-Cabanes, B., López-Picazo-Ferrer, JJ., Morales-Ortiz, A., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06094478

Hospital Implementation of a Stroke Protocol for ...

The HI-SPEED study will definitively establish the effectiveness and generalizability of a multi-component evidence-based DIDO intervention and provide ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11571713/

Impact and determinants of door in–door out time for stroke ...

Prolonged door in–door out (DIDO) times may have a deleterious effect on outcomes. Indeed, the effectiveness of reperfusion therapies exhibits a downward trend ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.119.025838

Door-in-Door-Out Time of 60 Minutes for Stroke With ...

Association of a primary stroke center protocol for suspected stroke by large-vessel occlusion with efficiency of care and patient outcomes.

4.

withpower.com

withpower.com/trial/phase-stroke-7-2024-b2085

HI-SPEED Protocol for Stroke (HI-SPEED Trial)

A streamlined protocol for managing acute ischemic stroke patients significantly reduced the time from hospital admission to reperfusion, which is crucial for ...

5.

ctv.veeva.com

ctv.veeva.com/study/hospital-implementation-of-a-stroke-protocol-for-emergency-evaluation-and-disposition

Hospital Implementation of a Stroke Protocol for Emergency ...

The HI-SPEED study will definitively establish the effectiveness and generalizability of a multi-component evidence-based DIDO intervention and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8649509/

Risk Assessment of the Door‐In‐Door‐Out Process at ...

This article reports the results of a FMECA of the DIDO process at PSCs leading to transfers of patients with acute stroke to CSCs and their ...