Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

NCT06113848 | Unknown Phase 3 DMC

• 1 other identifier: TJHH-2023-wm16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the feasibility and efficacy of intra-arterial TNK and albumin for patients with acute ischemic stroke after successful thrombectomy and whether there is a synergistic effect between TNK and albumin.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Albumin; TNK; No-reflow; Endovascular Therapy; Large Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• Number of participants with major response

  Major response is any of the following: 1. Any forms of intracranial hemorrhage; 2. Pulmonary edema; 3. Heart failure; 4. Skin itching, dyspnea and other allergic reactions; 5. Death of any causes.

  7 days after initiation of TNK or albumin intra-arterially

Study Arms (4)

Intra-Arterial TNK and Albumin

ACTIVE COMPARATOR

Drug: Intra-Arterial TNK and Albumin

Intra-Arterial TNK

ACTIVE COMPARATOR

Drug: Intra-Arterial TNK

Intra-Arterial Albumin

ACTIVE COMPARATOR

Drug: Intra-Arterial Albumin

sham

SHAM COMPARATOR

Other: sham

Interventions

Intra-Arterial TNK and Albumin DRUG

The study population was divided into four groups, one of which had intra-arterial TNK and albumin.

Intra-Arterial TNK and Albumin

Intra-Arterial TNK DRUG

The study population was divided into four groups, one of which had intra-arterial TNK .

Intra-Arterial TNK

Intra-Arterial Albumin DRUG

The study population was divided into four groups, one of which had intra-arterial albumin.

Intra-Arterial Albumin

sham OTHER

The study population was divided into four groups, one of which had no intra-arterial TNK and albumin.

sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AIS patients with large vessel occlusion;
• Age between 18 and 80 years;
• Baseline NIHSS score ≥ 6; 4 .Successful recanalization after thrombectomy (mTICI grades ≥ 2b);
• \. ASPECTS score ≥ 6 on CT; 6. First episode or previous episode without significant sequelae (mRS ≤ 2); 7. Time from onset to femoral artery puncture ≤ 24 hours; 8. Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

• Upon admission, the patient's medical history and physical examination revealed manifestations indicative of congestive heart failure (CHF), such as jugular venous distention, the presence of a third heart sound, resting tachycardia at a rate of 100 beats per minute attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or of unknown etiology;
• History of acute myocardial infarction within the preceding 3 months;
• The patient's medical history, electrocardiogram findings upon admission, or physical examination indicated the presence of second- or third-degree heart block or any arrhythmia associated with hemodynamic instability, as determined by the investigator's assessment;
• Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
• Severe anemia characterized by a hematocrit below 32%;
• Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
• Pregnancy status;
• Previous history of allergic reactions to albumin administration or TNK administration;
• Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration or TNK administration;
• Presence of other potentially life-threatening medical conditions;
• Individuals with current chronic lung diseases, such as chronic obstructive pulmonary disease, bronchiectasis, or any other lung disorder that significantly impairs daily activities;
• Individuals with known allergies to albumin or TNK;
• Patients with reocclusion within 24 hours;
• Clinical suspicion of aortic coarctation、 bacterial embolism and infective endocarditis;
• Patients with a history of coagulation disorders and systemic bleeding tendencies.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Albumins; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: September 7, 2023
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)