Ischemic StrokePROMISENCT02631317
Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China
An observational study of Ischemic Stroke and Adverse Effect of Thrombolytic Drugs, Sequela, run by First Affiliated Hospital of Jinan University.
Trial summary
PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Adverse Effect of Thrombolytic Drugs, Sequela
- What is being tested?
- Advance hospital notification by EMS, stroke team notification and key performance indicators feedback form
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,178 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: AIS patients with an onset-to-door time of less than 3.5 h
Who may be able to join
- All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent
Who cannot join
- Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack;
- Silent cerebral infarction without symptoms or signs;
About this study
PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). With a proposed "Reengineered Process Framework" for intravenous thrombolysis process by the PROMISE study steering committee, about 30 medical centers enters would be recruited nationwide, and each center would include consecutive AIS patients with an onset-to-door time (ODT) of less than 3.5 h. The investigators hypothesize that the proposed "Reengineered Process Framework" is suitable and feasible for hospitals in mainland of China; the rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h would be more than 20% or be increased by 40% as compared with baseline; the proportion of patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be with an increase by ≥ 40% as compared with baseline.
Read the detailed description
- After reviewing domestic and international clinical research literature, the PROMISE study steering committee constructed the "Reengineered Process Framework" for intravenous thrombolysis process with business process reengineering theory. The suggested "Reengineered Process Framework" is regarded as feasible and suitable for hospitals in mainland of China.
- The study period is 12 months, of which the first 3 months is the baseline period. After 3 months, all centers should develop new thrombolytic processes according to the "Reengineered Process Framework". The new processes are gradually implemented since the 4th month with continues care quality improvements.
- The "Reengineered Process Framework" adopts a form of comprehensive package, proposes unified key points of process reengineering, provides a series of supporting, standardized tools for process management, and establishes a real-time key performance indicator (KPI) monitoring feedback system, etc.
- Supporting, standardized tools includes: rapid identification tools of suspected stroke for medical personnel in the emergency system; stroke team building programs; real-time feedback form of KPI; standardized thrombolysis informed consent form and informed conversation public service advertising posters; suggested indications and contraindications for intravenous thrombolysis; standard operation procedure of intravenous rt-PA thrombolysis, etc.
With these methods, it is expected to raise the thrombolytic rate for patients arrived at medical center within 3.5 hours after the onset, and to shorten the door to needle time in China.
- Being tested
- Advance hospital notification by EMS, stroke team notification, key performance indicators feedback form, standard informed consent procedures, performance of thrombolysis at CT-room
- Keywords
- acute ischemic stroke, intravenous rt-PA thrombolysis, process reengineering, door-to-needle time
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance hospital notification by EMSBehavioural
Advance hospital notification by EMS
stroke team notificationBehavioural
stroke team notification
key performance indicators feedback formBehavioural
a "key performance indicators real-time feedback form" as continuing quality improvement
standard informed consent proceduresBehavioural
standard informed consent procedures with public poster of thrombolysis
performance of thrombolysis at CT-roomBehavioural
performance of thrombolysis at CT-room or emergency room
| Study group | Role | What they receive |
|---|---|---|
| rt-PA | patients treated with rt-PA, followed strategies were used: advance hospital notification by EMS, stroke team notification, key performance indicators feedback form, standard informed consent procedures, performance of thrombolysis at CT-room. Receives: Behavioral: Advance hospital notification by EMS; Behavioral: stroke team notification; Behavioral: key performance indicators feedback form; Behavioral: standard informed consent procedures; Behavioral: performance of thrombolysis at CT-room |
What is being measured
The primary outcome is the main question the study is designed to answer.
The thrombolysis rate of patients treated with rt-PA
The rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h: ≥ 20%, with an increase over the baseline ≥ 40%
Measured: within 4.5 hours
The rate of DNT less than 60 min within the patients treated with rt-PA
The rate of patients with a door-to-needle (DNT) time of less than 60 min for intravenous rt-PA thrombolysis: ≥20%, with an increase over the baseline ≥ 40%
Measured: within 4.5 hours
Secondary outcomes (3)
intravenous rt-PA thrombolysis with an ODT of less than 2 h
intravenous rt-PA thrombolysis in ischemic stroke patients with an onset-to-door time(ODT) of less than 2 h
Measured: 3 hours
death or dependence at 3-month
"death or dependence at 3-month" was defined as modified Rankin Scale(mRS) score 3-6 points.
Measured: 90 days
favorable outcome at 3-month
"favorable outcome at 3-month" was defined as mRS 0-1 points.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,178 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anding Xu, First Affiliated Hospital of Jinan University
- Investigators
- ANDING XU, Prof, Study chair, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631317
- Sponsor's protocol ID
- 2011BAI08B02-02
- Acronym
- PROMISE
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dong D, Lu L, He N, Zhang J, Wang Z, Xia H, Sun X, Geng Y, Liang H, Niu X, Zhang M, Xu D, Li N, Li J, Wang W, Zhang M, Zhang Z, Cao Y, Sun L, Zhou J, Li W, Li P, Fu J, Qiu W, Xue Y, Liu Y, Zhang J, Qiu W, Xing Y, Lu Z, Liu F, Wang S, Li J, Zang D, Liu J, Feng J, Bao Z, Zhang S, Wang Y, Xin X, Zhu H, Xu A. Impact of hospital process reengineering on door-to-needle time for intravenous thrombolysis in acute ischemic stroke (PROMISE-CHINA): a multicenter prospective pre-post quasi-experimental study. Front Neurol. 2026 Apr 10;17:1746553. doi: 10.3389/fneur.2026.1746553. eCollection 2026.
PubMed 42037720
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China
- ClinicalTrials.gov ID
- NCT02631317
- Acronym / sponsor ID
- PROMISE / 2011BAI08B02-02
- Keywords
- acute ischemic stroke, intravenous rt-PA thrombolysis, process reengineering, door-to-needle time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,178 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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.
PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). With a proposed "Reengineered Process Framework" for intravenous thrombolysis process by the PROMISE study steering committee, about 30 medical centers enters would be recruited nationwide, and each center would include consecutive AIS patients with an onset-to-door time (ODT) of less than 3.5 h. The investigators hypothesize that the proposed "Reengineered Process Framework" is suitable and feasible for hospitals in mainland of China; the rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h would be more than 20% or be increased by 40% as compared with baseline; the proportion of patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be with an increase by ≥ 40% as compared with baseline.
Detailed description
- After reviewing domestic and international clinical research literature, the PROMISE study steering committee constructed the "Reengineered Process Framework" for intravenous thrombolysis process with business process reengineering theory. The suggested "Reengineered Process Framework" is regarded as feasible and suitable for hospitals in mainland of China.
- The study period is 12 months, of which the first 3 months is the baseline period. After 3 months, all centers should develop new thrombolytic processes according to the "Reengineered Process Framework". The new processes are gradually implemented since the 4th month with continues care quality improvements.
- The "Reengineered Process Framework" adopts a form of comprehensive package, proposes unified key points of process reengineering, provides a series of supporting, standardized tools for process management, and establishes a real-time key performance indicator (KPI) monitoring feedback system, etc.
- Supporting, standardized tools includes: rapid identification tools of suspected stroke for medical personnel in the emergency system; stroke team building programs; real-time feedback form of KPI; standardized thrombolysis informed consent form and informed conversation public service advertising posters; suggested indications and contraindications for intravenous thrombolysis; standard operation procedure of intravenous rt-PA thrombolysis, etc.
With these methods, it is expected to raise the thrombolytic rate for patients arrived at medical center within 3.5 hours after the onset, and to shorten the door to needle time in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rt-PA | – | Behavioral: Advance hospital notification by EMS, Behavioral: stroke team notification, Behavioral: key performance indicators feedback form, Behavioral: standard informed consent procedures, Behavioral: performance of thrombolysis at CT-roompatients treated with rt-PA, followed strategies were used: advance hospital notification by EMS, stroke team notification, key performance indicators feedback form, standard informed consent procedures, performance of thrombolysis at CT-room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AIS patients with an onset-to-door time of less than 3.5 h
Key inclusion criteria (1 listed)
- All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent
Key exclusion criteria (2 listed)
- Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack;
- Silent cerebral infarction without symptoms or signs;
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 |
|---|---|---|
| Advance hospital notification by EMSAdvance hospital notification by EMS | Behavioural | rt-PA |
| stroke team notificationstroke team notification | Behavioural | rt-PA |
| key performance indicators feedback forma "key performance indicators real-time feedback form" as continuing quality improvement | Behavioural | rt-PA |
| standard informed consent proceduresstandard informed consent procedures with public poster of thrombolysis | Behavioural | rt-PA |
| performance of thrombolysis at CT-roomperformance of thrombolysis at CT-room or emergency room | Behavioural | rt-PA |
Primary outcome
The thrombolysis rate of patients treated with rt-PA
Time frame: within 4.5 hours
The rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h: ≥ 20%, with an increase over the baseline ≥ 40%
The rate of DNT less than 60 min within the patients treated with rt-PA
Time frame: within 4.5 hours
The rate of patients with a door-to-needle (DNT) time of less than 60 min for intravenous rt-PA thrombolysis: ≥20%, with an increase over the baseline ≥ 40%
3 secondary outcomes
intravenous rt-PA thrombolysis with an ODT of less than 2 h
Time frame: 3 hours
death or dependence at 3-month
Time frame: 90 days
favorable outcome at 3-month
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Derived from this study: PubMed 42037720Dong D, Lu L, He N, Zhang J, Wang Z, Xia H, Sun X, Geng Y, Liang H, Niu X, Zhang M, Xu D, Li N, Li J, Wang W, Zhang M, Zhang Z, Cao Y, Sun L, Zhou J, Li W, Li P, Fu J, Qiu W, Xue Y, Liu Y, Zhang J, Qiu W, Xing Y, Lu Z, Liu F, Wang S, Li J, Zang D, Liu J, Feng J, Bao Z, Zhang S, Wang Y, Xin X, Zhu H, Xu A. Impact of hospital process reengineering on door-to-needle time for intravenous thrombolysis in acute ischemic stroke (PROMISE-CHINA): a multicenter prospective pre-post quasi-experimental study. Front Neurol. 2026 Apr 10;17:1746553. doi: 10.3389/fneur.2026.1746553. eCollection 2026.
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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. This study is not recruiting at the moment.
ANDING XU, Prof study chair
Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Adverse Effect of Thrombolytic Drugs, Sequela, run by First Affiliated Hospital of Jinan University.
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 1 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: finished, as of the sponsor's last update on 5 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The thrombolysis rate of patients treated with rt-PA (time frame: within 4.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631317, which also lists 1 linked publication.
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 5 Feb 2016.