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Not yet recruitingNCT07865598OPTINursingUpdated Oct 8, 2026

Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke

An interventional study of lower frequency of assessment of neurological impairment and vital signs and standard frequency of assessment of neurological impairment and vital signs in Stroke, Ischemic, sponsored by Shengjing Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Shengjing Hospital · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
864
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Stroke, Ischemic

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Keywords

  • thrombolysis
  • acute ischemic stroke
  • nursing
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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 864 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 125 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults aged 18 years or older;
  2. diagnosis of acute ischemic stroke;
  3. treatment with intravenous alteplase, tenecteplase, or an equivalent thrombolytic agent as part of clinical care;
  4. stable vital signs with blood pressure no higher than 180/105 mmHg;
  5. and mild-to-moderate neurological deficit assessed by a clinician 2 hours after thrombolysis, for example NIHSS less than 10.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. or anticipated immediate transfer, dialysis-related transfer, palliative management, or surgery that is incompatible with adherence to the low-intensity monitoring pathway.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
864 participants (estimated)

Study arms

  • Experimental
    Low-Intensity Monitoring

    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.

    Procedure: lower frequency of assessment of neurological impairment and vital signs

  • Active comparator
    Standard Monitoring

    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.

    Procedure: standard frequency of assessment of neurological impairment and vital signs

Interventions

  • Procedurelower frequency of assessment of neurological impairment and vital signs

    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.

  • Procedurestandard frequency of assessment of neurological impairment and vital signs

    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.

06

What researchers measure

Primary outcomes

  1. Objective Nursing Workload

    Time frame: 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

    Time frame: During index hospitalization, up to 7 days, using MISSCARE Survey.

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865598
Lead sponsor
Shengjing Hospital
Responsible party
Anhua Wu (President of Shengjing Hospital, Director of Neurosurgery, Shengjing Hospital) — Principal investigator
First posted
Oct 8, 2026
Start date
Dec 2026 (estimated)
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Oct 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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