Stroke, IschemicOPTINursingNCT07865598
Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke
A study testing lower frequency of assessment of neurological impairment and vital signs and standard frequency of assessment of neurological impairment and vital signs in people with Stroke, Ischemic, run by Shengjing Hospital.
Trial summary
This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- lower frequency of assessment of neurological impairment and vital signs and standard frequency of assessment of neurological impairment and vital signs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older;
- diagnosis of acute ischemic stroke;
- treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;
- stable vital signs with blood pressure no higher than 180/105 mmHg;
- and mild-to-moderate neurological deficit assessed by a clinician 2 hours after thrombolysis, for example NIHSS less than 10.
Who cannot join
- A clear clinical contraindication to low-intensity monitoring, including need for intensive care or prolonged intensive monitoring, severe neurological deficit, early neurological deterioration or substantial risk of deterioration, need for airway support, or need for intravenous treatment unavailable on a general ward;
- or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.
About this study
Official title: Effect of Low-Intensity Monitoring Frequency After Intravenous Thrombolysis for Acute Ischemic Stroke on Nursing Workload and Missed Nursing Care: A Multicenter, Open-Label, Randomized, Blinded-Endpoint Trial
This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period.
Read the detailed description
Intravenous thrombolysis is an established reperfusion treatment for eligible patients with acute ischemic stroke, but post-thrombolysis monitoring is resource intensive. This study will evaluate whether a lower scheduled monitoring frequency can reduce nursing workload without causing a clinically important increase in missed nursing care or compromising clinical safety. Hospitals will be randomized in a 1:1 ratio to a low-intensity monitoring pathway or a standard-intensity monitoring pathway.
- Conditions
- Stroke, Ischemic
- Being tested
- lower frequency of assessment of neurological impairment and vital signs, standard frequency of assessment of neurological impairment and vital signs
- Keywords
- thrombolysis, acute ischemic stroke, nursing
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower frequency of assessment of neurological impairment and vital signsProcedure or surgery
Participants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 2 hours during the next 8 hours, and every 4 hours during the subsequent 14 hours. Additional clinically indicated monitoring is permitted and required.
standard frequency of assessment of neurological impairment and vital signsProcedure or surgery
Participants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 30 minutes during the subsequent 6 hours, and every 60 minutes during the subsequent 16 hours. Additional clinically indicated monitoring is permitted and required.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Monitoring | Experimental | Participants at assigned hospitals will receive a reduced scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated. Receives: Procedure: lower frequency of assessment of neurological impairment and vital signs |
| Standard Monitoring | Active comparator | Participants at assigned hospitals will receive the study standard scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated. Receives: Procedure: standard frequency of assessment of neurological impairment and vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Nursing Workload
Measured: From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.
Secondary outcomes (1)
Missed Nursing Care
Measured: During index hospitalization, up to 7 days, using MISSCARE Survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startDec 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anhua Wu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865598
- Sponsor's protocol ID
- OPTINursing202609SY
- Acronym
- OPTINursing
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Intensity Monitoring Frequency After Intravenous Thrombolysis for Acute Ischemic Stroke on Nursing Workload and Missed Nursing Care: A Multicenter, Open-Label, Randomized, Blinded-Endpoint Trial
- ClinicalTrials.gov ID
- NCT07865598
- Acronym / sponsor ID
- OPTINursing / OPTINursing202609SY
- Conditions
- Stroke, Ischemic
- Keywords
- thrombolysis, acute ischemic stroke, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period.
Detailed description
Intravenous thrombolysis is an established reperfusion treatment for eligible patients with acute ischemic stroke, but post-thrombolysis monitoring is resource intensive. This study will evaluate whether a lower scheduled monitoring frequency can reduce nursing workload without causing a clinically important increase in missed nursing care or compromising clinical safety. Hospitals will be randomized in a 1:1 ratio to a low-intensity monitoring pathway or a standard-intensity monitoring pathway.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Monitoring | Experimental | Procedure: lower frequency of assessment of neurological impairment and vital signsParticipants at assigned hospitals will receive a reduced scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated. |
| Standard Monitoring | Active comparator | Procedure: standard frequency of assessment of neurological impairment and vital signsParticipants at assigned hospitals will receive the study standard scheduled nursing monitoring pathway during the first 24 hours after intravenous thrombolysis. Additional assessment or clinical escalation is permitted when indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older;
- diagnosis of acute ischemic stroke;
- treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;
- stable vital signs with blood pressure no higher than 180/105 mmHg;
- and mild-to-moderate neurological deficit assessed by a clinician 2 hours after thrombolysis, for example NIHSS less than 10.
Key exclusion criteria (2 listed)
- A clear clinical contraindication to low-intensity monitoring, including need for intensive care or prolonged intensive monitoring, severe neurological deficit, early neurological deterioration or substantial risk of deterioration, need for airway support, or need for intravenous treatment unavailable on a general ward;
- or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower frequency of assessment of neurological impairment and vital signsParticipants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 2 hours during the next 8 hours, and every 4 hours during the subsequent 14 hours. Additional clinically indicated monitoring is permitted and required. | Procedure or surgery | Low-Intensity Monitoring |
| standard frequency of assessment of neurological impairment and vital signsParticipants receive neurological assessment and heart rate/blood pressure assessment every 15 minutes during the first 2 hours after initiation of thrombolytic infusion, every 30 minutes during the subsequent 6 hours, and every 60 minutes during the subsequent 16 hours. Additional clinically indicated monitoring is permitted and required. | Procedure or surgery | Standard Monitoring |
Primary outcome
Objective Nursing Workload
Time frame: From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.
1 secondary outcome
Missed Nursing Care
Time frame: During index hospitalization, up to 7 days, using MISSCARE Survey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lower frequency of assessment of neurological impairment and vital signs and standard frequency of assessment of neurological impairment and vital signs in people with Stroke, Ischemic, run by Shengjing Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Nursing Workload (time frame: From baseline to 24 hours: total time spent on post-thrombolysis nursing monitoring activities, recorded in minutes per participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.