Recruiting NA Intracerebral Haemorrhage

New treatment option for Intracerebral Haemorrhage

Official title Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

ClinicalTrials.gov ID: NCT07208097

What this study is testing

What it's testing
This is an phase III prospective, multi-center, open-label, randomized controlled trial (RCT) with blinded endpoint assessment. It plans to enroll 768 subjects with spontaneous supratentorial intracerebral hemorrhage, who will be randomly assigned in a 1:1 ratio to the investigational arm (stereotactic minimally invasive puncture for intracerebral hemorrhage combined with TNK liquefaction drainage, single TNK dose of 0.5mg per time or the standard medical treatment group.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • . Age 18 to 80 years, any gender.
  • . Clinically confirmed acute spontaneous supratentorial intracerebral hemorrhage (ICH), with diagnostic CT completed within 24 hours of symptom onset...
  • . CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive).
  • . National Institutes of Health Stroke Scale (NIHSS) score ≥ 6.
  • .Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive).

You likely can't join if

  • . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated...
  • . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing).
  • . Secondary ICH caused by: head trauma, arteriovenous malformation (AVM), moyamoya disease, intracranial aneurysm, coagulation disorders (hereditary...
  • . Significant abnormalities in the following laboratory parameters:(1)International normalized ratio (INR) \> 1.4; any irreversible coagulopathy or...
  • . History of malignancy, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis), hemorrhagic diathesis...
  • . Known high risk of thromboembolism, including: presence of a mechanical heart valve prosthesis, history of left heart thrombus, mitral stenosis...
See the full eligibility criteria
Who can join
  • . Age 18 to 80 years, any gender.
  • . Clinically confirmed acute spontaneous supratentorial intracerebral hemorrhage (ICH), with diagnostic CT completed within 24 hours of symptom onset (for patients with unknown time of onset or wake-up stroke, the time...
  • . CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive).
  • . National Institutes of Health Stroke Scale (NIHSS) score ≥ 6.
  • .Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive).
  • . Pre-stroke modified Rankin Scale (mRS) score ≤ 1.
  • . Good compliance, with written informed consent provided by the patient and/or legal guardian, and ability to adhere to the scheduled follow-up visits.
What rules you out
  • . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils.
  • . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing).
  • . Secondary ICH caused by: head trauma, arteriovenous malformation (AVM), moyamoya disease, intracranial aneurysm, coagulation disorders (hereditary or acquired hemorrhagic diathesis, hemophilia, coagulation factor...
  • . Significant abnormalities in the following laboratory parameters:(1)International normalized ratio (INR) \> 1.4; any irreversible coagulopathy or known coagulation disorder that cannot be corrected with procoagulants...
  • . History of malignancy, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis), hemorrhagic diathesis (including various hereditary and acquired bleeding disorders)...
  • . Known high risk of thromboembolism, including: presence of a mechanical heart valve prosthesis, history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial...
  • . Myocardial infarction within 30 days prior to randomization.
  • .Use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) within 1 week prior to symptom onset.
  • . History of internal bleeding (e.g., gastrointestinal bleeding, genitourinary bleeding, retroperitoneal bleeding) within 3 months prior to randomization.
  • . Major surgery or vascular puncture (e.g., venesection, arterial puncture) within 3 months prior to randomization.
  • . History of significant head trauma or severe stroke within 3 months prior to randomization.
  • . History of intracerebral hemorrhage within 1 year prior to randomization.
  • . Indications for craniotomy: (1) Progressive impairment of consciousness; (2)Preoperative signs of brain herniation (e.g., foramen magnum herniation, tentorial herniation) posing a life-threatening condition.
  • . Intraventricular hemorrhage (IVH) or ICH with rupture into the ventricle causing intraventricular cast formation and/or hydrocephalus anticipated to require external ventricular drainage (EVD).
  • . Patient or family requests craniotomy or neuroendoscopic surgery for hematoma evacuation.
  • . Pre-randomization decision by patient/family for Do-Not-Resuscitate (DNR) or Do-Not-Intubate (DNI) orders regarding life-sustaining measures.
  • . Known hypersensitivity or intolerance to TNK.
  • . Pregnancy (positive urine pregnancy test) in women of childbearing potential.
  • . Concurrent participation in another investigational drug or device study.
  • . History of drug or alcohol abuse/dependence, severe dementia, or psychiatric disorder prior to randomization, anticipated to result in poor compliance and inability to complete follow-up.

The study team makes the final eligibility decision.

Where it's taking place

  • Suzhou, Anhui, China
  • Guiyang, Guizhou, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Suzhou, Anhui, China; Guiyang, Guizhou, China. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.