Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

The Affiliated Hospital Of Guizhou Medical University

Status: Enrolling

Conditions: Aneurysmal Subarachnoid Hemorrhage; Vasospasm

Treatments: Drug: Intrathecal Nicardipine; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06329635

2023070K

Details and patient eligibility

About

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Full description

Objective:

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Design:

This study is a multi-center, prospective, double-blinded, randomized controlled trial.

Interventions:

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).

Enrollment: 396 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80.

2. Spontaneous SAH confirmed by head CT.

3. Saccular brain aneurysm is identified and treated, either surgically or endovascularly.

4. SAH Fisher grade >1 or modified Fisher grade >0.

5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.

6. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:

   1. Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.
   2. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upward trend of mean flow velocity for 2 consecutive days (>25cm/s/day).
   3. Clinical deterioration including mental status change (GCS score decrease > 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
   4. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.

7. Within 14 days of onset of SAH.

8. Informed consent obtained from the patient or family member.

Exclusion criteria

1. Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
2. Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
3. The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
4. History of head trauma within the past 3 months.
5. Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
6. History of psychiatric disorders or seizures within 3 months.
7. Severe concurrent medical conditions.
8. Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
9. Lactating women.
10. Life expectancy of less than 1 year prior to aSAH onset.
11. Pre-morbid mRS score >1.
12. Participation in another randomized clinical trial that may confound the evaluation of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 2 patient groups

Intrathecal Treatment Group

Experimental group

Description:

The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.

Treatment:

Drug: Intrathecal Nicardipine

Control Group

Sham Comparator group

Description:

The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.

Treatment:

Other: No intervention