Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy

Last updated: October 27, 2023
Sponsor: Tianjin Huanhu Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Cerebral Ischemia

Stroke

Treatment

sham

Intra-Arterial TNK

Intra-Arterial TNK and Albumin

Clinical Study ID

NCT06113848
TJHH-2023-wm16
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

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

Exclusion

Exclusion criteria:

  1. Upon admission, the patient's medical history and physical examination revealedmanifestations indicative of congestive heart failure (CHF), such as jugular venousdistention, the presence of a third heart sound, resting tachycardia at a rate of 100beats per minute attributable to heart failure, hepatomegaly, and/or lower extremityedema attributable to heart failure or of unknown etiology;
  2. History of acute myocardial infarction within the preceding 3 months;
  3. The patient's medical history, electrocardiogram findings upon admission, or physicalexamination indicated the presence of second- or third-degree heart block or anyarrhythmia associated with hemodynamic instability, as determined by theinvestigator's assessment;
  4. Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
  5. Severe anemia characterized by a hematocrit below 32%;
  6. Computed tomography findings upon admission indicating the presence of any form ofhemorrhage;
  7. Pregnancy status;
  8. Previous history of allergic reactions to albumin administration or TNKadministration;
  9. Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albuminadministration or TNK administration;
  10. Presence of other potentially life-threatening medical conditions;
  11. Individuals with current chronic lung diseases, such as chronic obstructive pulmonarydisease, bronchiectasis, or any other lung disorder that significantly impairs dailyactivities;
  12. Individuals with known allergies to albumin or TNK;
  13. Patients with reocclusion within 24 hours;
  14. Clinical suspicion of aortic coarctation、 bacterial embolism and infectiveendocarditis;
  15. Patients with a history of coagulation disorders and systemic bleeding tendencies.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: sham
Phase: 3
Study Start date:
September 07, 2023
Estimated Completion Date:
September 07, 2024

Study Description

Endovascular therapy is the first-line treatment for acute ischemic stroke with large vessel occlusion. However, many studies have shown that, even with successful recanalization, about half of patients do not achieve functional independence. This phenomenon is called futile recanalization, which is partly attributed to brain no-reflow (microcirculation reperfusion failure despite recanalization of the occluded large artery). The mechanisms of brain no-reflow phenomenon include inflammation, micro thrombosis, aggregation platelets and red blood cells, and pericyte contraction.

Albumin, the most copious plasma protein synthesized primarily in the liver, possesses various biochemical properties, including anti-inflammatory, inhibiting platelet aggregation and micro thrombosis formation, and increasing microvascular perfusion. All of these properties are directed toward the mechanisms of no-reflow production, so albumin may inhibit no-reflow to improve the prognosis of stroke patients. TNK is a new generation thrombolytic agent that inhibits thrombosis, improves microcirculatory perfusion, and may inhibit no-reflow. These functions of TNK are similar to those of albumin, and the two also can reduce infraction volume and cerebral edema, and improve of behavioral function. In this study, we plan to determine the feasibility and efficacy of intra-arterial TNK and albumin for stroke patients undergoing successful mechanical thrombectomy and whether there is a synergistic effect between TNK and albumin.

Connect with a study center

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin 300222
    China

    Active - Recruiting

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