HI-SPEED Protocol for Stroke

(HI-SPEED Trial)

Recruiting at 4 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

Trial Summary

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 data supports the effectiveness of the HI-SPEED Protocol treatment for stroke?

The HI-SPEED Protocol for stroke aims to reduce the time from hospital admission to treatment, similar to protocols used in other conditions like heart attacks, where faster treatment times have been linked to better outcomes. Research shows that streamlined processes and interdisciplinary collaboration can significantly reduce treatment times and improve patient outcomes in acute ischemic stroke. ^{1 2 3 4 5}

Is the HI-SPEED Protocol for Stroke generally safe for humans?

The HI-SPEED Protocol, which involves thrombolytic therapy (using drugs to dissolve blood clots), has been used safely in patients with ischemic stroke, as shown in several studies. These studies report no major safety issues like intracranial hemorrhage (bleeding in the brain) when following strict protocols. ^{6 7 8 9 10}

How does the HI-SPEED Protocol treatment for stroke differ from other treatments?

The HI-SPEED Protocol, also known as the Door-In-Door-Out Protocol, focuses on minimizing the time it takes to transfer stroke patients from a non-specialized hospital to a comprehensive stroke center for advanced treatment. This approach is unique because it emphasizes reducing delays in the transfer process, which is crucial for timely intervention in stroke care. ^{2 3 4 5 11}

What is the purpose of this trial?

Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.

Research Team

Shyam Prabhakaran, MD, MS

Principal Investigator

University of Chicago

Jane Holl, MD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimized Management of Endovascular Treatment for Acute Ischemic Stroke. [2018]

2. United States 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. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Factors associated with door-in-door-out times in large vessel occlusion stroke patients undergoing endovascular therapy. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Reducing Door-In to Door-Out Time for Patients Receiving a Mechanical Thrombectomy Using AutoLaunch Protocol. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Association Between Hospital Practices and Door-in-door-out Time in ST-segment Elevation Myocardial Infarction. [2018]

6. United States 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. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

[Thrombolysis in acute ischemic stroke in basic hospitals. four cases reports]. [2016]

8. Italy pubmed.ncbi.nlm.nih.gov

The Belgian experience with intravenous thrombolysis for acute ischemic stroke. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

[Why is reperfusion therapy delayed in stroke code patients? A qualitative analysis]. [2018]

10. England 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. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Air vs. Road Decision for Endovascular Clot Retrieval in a Rural Telestroke Network. [2020]