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Completed

NCT Number: NCT02631317

Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent

Exclusion criteria

  • Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack;
  • Silent cerebral infarction without symptoms or signs;

Treatment and study plan

Advance hospital notification by EMS

Behavioral

Advance hospital notification by EMS

stroke team notification

Behavioral

stroke team notification

key performance indicators feedback form

Behavioral

a "key performance indicators real-time feedback form" as continuing quality improvement

standard informed consent procedures

Behavioral

standard informed consent procedures with public poster of thrombolysis

performance of thrombolysis at CT-room

Behavioral

performance of thrombolysis at CT-room or emergency room

Primary outcomes

  1. 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%

  2. 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%

Secondary outcomes

  1. intravenous rt-PA thrombolysis with an ODT of less than 2 h

    Time frame: 3 hours

    intravenous rt-PA thrombolysis in ischemic stroke patients with an onset-to-door time(ODT) of less than 2 h

  2. death or dependence at 3-month

    Time frame: 90 days

    "death or dependence at 3-month" was defined as modified Rankin Scale(mRS) score 3-6 points.

  3. favorable outcome at 3-month

    Time frame: 90 days

    "favorable outcome at 3-month" was defined as mRS 0-1 points.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Jinan University

Other

Registry information

Acronym: PROMISE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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