Stroke, IschemicHASTENCT05570682
Manually Controlled Infusion Vs Target Controlled Infusion for StrokeThrombectomy
A study testing TCI and Manual induction in people with Stroke, Ischemic and Stroke/Brain Attack, run by University of Padova at 1 site in Italy.
Trial summary
The goal of this randomized controlled trial is to compare manual general anesthesia induction to general anesthesia induction guided by target controlled infusion system in cerebral ischemic stroke The main questions it aims to answer are: Does target controlled infusion has a more favorauble hemodynamic profile than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke/Brain Attack, Anesthesia
- What is being tested?
- TCI and Manual induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2022to 9 Oct 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years;
- Anterior Cerebral Circulation Stroke
- Patient eligible for mechanical trombectomy
- mRS ≤ 2;
- Fasting patients (>6 h solid, >2 hours liquids)
- Glashow Coma Scale more than seven.
Who cannot join
- Patient in general anesthesia at hospital arrival
- Associated hemorrhagic stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manually Controlled Infusion Vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial
The goal of this randomized controlled trial is to compare manual general anesthesia induction to general anesthesia induction guided by target controlled infusion system in cerebral ischemic stroke
The main questions it aims to answer are:
- Does target controlled infusion has a more favorauble hemodynamic profile than manual general anesthesia induction?
- Do patients receiving general anesthesia with target controlled infusion system have a more favourable outcome? Participants will receive general anesthesia induction with a target controlled infusion system and will be compared to patients receiving manual general anesthesia induction.
- Being tested
- TCI, Manual induction
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCIProcedure or surgery
General anesthesia will be induced with a TCI pump
Manual inductionProcedure or surgery
General anestehsia will be induced and maintained using a pro kilo regimen.
| Study group | Role | What they receive |
|---|---|---|
| Manual induction | Active comparator | General Anesthesia induction: Fentanyl 2 mcg/kg, Propofol 2 mg/kg, Rocuronium 0.6 mg/kg General Anesthesia mainteneance: Propofol 4-6 mg/kg/h to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) Receives: Procedure: Manual induction |
| Target Controlled Induction | Experimental | General Anesthesia induction: Fentanyl 2 mcg/kg, Propofol TCI with Schneider site effect model starting from 2 mcg/ml and increasing the dose untile loss of consciousness, Rocuronium 0.6 mg/kg.
General Anesthesia mainteneance: Propofol TCI with Schneider site effect model in order to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) Receives: Procedure: TCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Intraprocedural Hypotension
Descrease of mean blood pressure > 20% during the procedure from the baseline
Measured: Up to three hours
Secondary outcomes (8)
Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) at 24 hours after acute ischemic stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Measured: 24 hours after acute ischemic stroke
Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) at 7 days after acute ischemic stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Measured: 7 days after acute ischemic stroke
Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke
Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke. Modified Rankin Score is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is added for patients who expire.
Measured: 3 months after acute ischemic stroke
Percentage of patients alive at 3 months after acute ischemic stroke
Percentage of patients alive at 3 months after acute ischemic stroke
Measured: 3 months after acute ischemic stroke
Difference in modified treatment in cerebral infarction (mTICI) score
Successfull reperfusion in the two groups will be evaluated by modified tratment in cerebral infarction score. modified treatment in cerebral infarction is a five point score (0,1,2a,2b,3) with 0 menaning o reperfusion and 3 complete reperfusion
Measured: 24 hours after ischemic stroke
Difference in time from door to groin
Time will be evaluated from patient admission to the beginning of angiographic procedure
Measured: Up to 6 hours
Difference in time from groin to reperfusion
It will be evaluated the overall time of angiographic procedure
Measured: Up to 6 hours
Difference in Intensive Care Unit/Stroke Unit stay
Overall patient stay in intensive care unit/stroke unit in days
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start9 Oct 2022
- Primary completion9 Oct 2022
- Study completion9 Oct 2022
Why it stopped: No particpants was enrolled as after IRB cleareance there was no more logistical feasibiliy to enroll patients.
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570682
- Sponsor's protocol ID
- HASTE
- Acronym
- HASTE
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manually Controlled Infusion Vs Target Controlled Infusion: an Hemodynamic Alterations in StrokeThrombectomy Evaluation (HASTE); a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05570682
- Acronym / sponsor ID
- HASTE / HASTE
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No particpants was enrolled as after IRB cleareance there was no more logistical feasibiliy to enroll patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 6 Oct 2022 (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.
The goal of this randomized controlled trial is to compare manual general anesthesia induction to general anesthesia induction guided by target controlled infusion system in cerebral ischemic stroke
The main questions it aims to answer are:
- Does target controlled infusion has a more favorauble hemodynamic profile than manual general anesthesia induction?
- Do patients receiving general anesthesia with target controlled infusion system have a more favourable outcome? Participants will receive general anesthesia induction with a target controlled infusion system and will be compared to patients receiving manual general anesthesia induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual induction | Active comparator | Procedure: Manual inductionGeneral Anesthesia induction: Fentanyl 2 mcg/kg, Propofol 2 mg/kg, Rocuronium 0.6 mg/kg General Anesthesia mainteneance: Propofol 4-6 mg/kg/h to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) |
| Target Controlled Induction | Experimental | Procedure: TCIGeneral Anesthesia induction: Fentanyl 2 mcg/kg, Propofol TCI with Schneider site effect model starting from 2 mcg/ml and increasing the dose untile loss of consciousness, Rocuronium 0.6 mg/kg. General Anesthesia mainteneance: Propofol TCI with Schneider site effect model in order to keep an adequate sedation level (BIS between 40-60; entropy between 40-60) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Anterior Cerebral Circulation Stroke
- Patient eligible for mechanical trombectomy
- mRS ≤ 2;
- Fasting patients (>6 h solid, >2 hours liquids)
Key exclusion criteria (2 listed)
- Patient in general anesthesia at hospital arrival
- Associated hemorrhagic stroke
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 |
|---|---|---|
| TCIGeneral anesthesia will be induced with a TCI pump | Procedure or surgery | Target Controlled Induction |
| Manual inductionGeneral anestehsia will be induced and maintained using a pro kilo regimen. | Procedure or surgery | Manual induction |
Primary outcome
Number of patients with Intraprocedural Hypotension
Time frame: Up to three hours
Descrease of mean blood pressure > 20% during the procedure from the baseline
8 secondary outcomes
Change from baseline in National Institutes of Health Stroke Scale at 24 hours after acute ischemic stroke
Time frame: 24 hours after acute ischemic stroke
Change from baseline in National Institutes of Health Stroke Scale at 7 days after acute ischemic stroke
Time frame: 7 days after acute ischemic stroke
Evaluation of Modified Rankin Scale at 3 months after acute ischemic stroke
Time frame: 3 months after acute ischemic stroke
Percentage of patients alive at 3 months after acute ischemic stroke
Time frame: 3 months after acute ischemic stroke
Difference in modified treatment in cerebral infarction (mTICI) score
Time frame: 24 hours after ischemic stroke
Difference in time from door to groin
Time frame: Up to 6 hours
Difference in time from groin to reperfusion
Time frame: Up to 6 hours
Difference in Intensive Care Unit/Stroke Unit stay
Time frame: Up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI and Manual induction in people with Stroke, Ischemic and Stroke/Brain Attack, run by University of Padova at 1 site in Italy.
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 6 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: withdrawn, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with Intraprocedural Hypotension (time frame: Up to three hours). 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 28 Mar 2025.