NCT02974283

Brief Summary

The purpose of this study is to find out a serum marker for the evaluation of blood brain barrier damage based on animal experiments and investigate the effect of NBO（Normobaric hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA thrombolytic therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Stroke, Acute

Keywords

Normobaric hyperoxiar-tPA thrombolytic therapy

Outcome Measures

Primary Outcomes (2)

  • levels of blood biomarkers

    a serum marker for the evaluation of blood brain barrier damage based on animal experiments

    7days

  • Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

    7days

Secondary Outcomes (1)

  • Number of participants with adverse events that are related to treatment

    7days

Study Arms (2)

NBO group

EXPERIMENTAL

Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start within 1 hours after diagnosis of ischemic stroke and last for 4hours. All participants will receive r-tPA thrombolytic therapy and a standard clinical therapy.

Other: Normobaric oxygen therapy

Control group

NO INTERVENTION

The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.

Interventions

Normobaric oxygen therapyOTHER

In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. . Other Names:

NBO group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female with age from 18 to 85;
  • Acute ischemic stroke;
  • National Institutes of Health Stroke Scale (NIHSS) score of 4-25
  • mRS score less than 1 before onset of stroke symptom;
  • Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA thrombolytic therapy;
  • Informed consent obtained

You may not qualify if:

  • Stroke or serious head trauma within the previous 3 months
  • Major surgery or severe trauma with in the preceding 3 months
  • Intracranial hemorrhage
  • Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
  • Symptoms rapidly improving
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
  • Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
  • Arterial puncture at a noncompressible site within the previous 7 days
  • Seizure at the onset of stroke
  • Platelet count of less than 100,000 per cubic millimeter
  • Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
  • Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
  • CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
  • severe hepatic or renal dysfunction
  • active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shi S, Qi Z, Ma Q, Pan R, Timmins GS, Zhao Y, Shi W, Zhang Y, Ji X, Liu KJ. Normobaric Hyperoxia Reduces Blood Occludin Fragments in Rats and Patients With Acute Ischemic Stroke. Stroke. 2017 Oct;48(10):2848-2854. doi: 10.1161/STROKEAHA.117.017713. Epub 2017 Sep 20.

    PMID: 28931617DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xunming Ji, MD. Ph.D

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD. Ph.D

CONTACT

+86-10-83198952jixunming@vip.163.com

Shuhai Shi, Ph.D.

CONTACT

+86-13-311145865shishuhai100@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 28, 2016

Record last verified: 2016-11