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Completed

NCT Number: NCT03218293

Thrombolysis and RIPC in Acute Ischemic Stroke

Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).

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Key information

Conditions

Acute Ischemic Stroke, Cerebral Embolism and Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism Intracranial Embolism and Thrombosis Ischemic Stroke Nervous System Diseases Stroke Thromboembolism Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • In accordance with the Guideline of Thrombolysis in Acute Ischemic Stroke and accomplish intravenous thrombolytic therapy using alteplase;
  • The consciousness of patients are conscious,somnolence,confusion and stupor，can comply better with the RIPC treatment;
  • Acute ischemic stroke confirmed by cranial CT/MRI;
  • Provision of written informed consent.

Exclusion criteria

  • History of cerebral embolism,cerebral hemorrhage, brain tumor, brain trauma or other brain lesion;
  • Severe cardiac, liver, or kidney disease, malignancy, systemic organ dysfunction;
  • Blood pressure <90/60 mmHg or >200/110 mmHg after treatment;
  • Dementia or mental illness;
  • History of major surgery or trauma 4 weeks prior to admission;
  • Failure to provide informed consent.

Treatment and study plan

RIPC device (IPC-906X)

Device

Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis.

Other names: Thrombolysis

Primary outcomes

  1. the percentage of patients with a favorable outcome, defined as a score of 0 or 1 on the modified Rankin scale (mRS).

    Time frame: Day 90

Secondary outcomes

  1. the percentage of functional recovery at discharge and at day 90, as measured by the NIHSS, the Barthel index (BI) and the mRS

    Time frame: Day 90 and at discharge(up to day 14)

    we measured how many patients achieved a score of 0 or 1 for the NIHSS, 95 for the BI, and 0 - 2 for the mRS.

  2. Plasma biomarker concentrations

    Time frame: Day 1 and at discharge ( up to day 14)

    Venous blood was drawn before the administration of IV tPA and at the end of hospitalization to determine the effect of repeated RIPC on anti-inflammatory (S100-β), vascular (VEGF, bFGF), anti-edema (MMP9), anti-oxidants (OH1) and other pathways (BDNF, HSP).

Other outcomes

  1. mortality rate

    Time frame: up to 3 months.

    three-month mortality rate

  2. the rate of symptomatic hemorrhagic transformation

    Time frame: up to 36 hours

    Defined by European Cooperative Acute Stroke Study III classification

  3. Early neurological deterioration

    Time frame: up to 24 hours after IV tPA

  4. The tolerance index

    Time frame: up to 14 days

    the proportion of patients that could complete every RIPC treatment session during his/her hospital stay.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.

Acronym: tripcais

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2017
Registry last updated
Aug 23, 2021

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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