Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.

  • STATUS
    Recruiting
  • End date
    Mar 4, 2023
  • participants needed
    440
  • sponsor
    University Hospital, Caen
Updated on 4 July 2021
drainage
aneurysm
stroke
hydrocephalus
cerebral infarction
alteplase
intracranial aneurysm
fibrinolysis
tissue plasminogen activator
aneurysmal subarachnoid hemorrhage
delayed cerebral ischaemia

Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with delayed cerebral ischemia (DCI) as a major complication. There are several evidences, both in preclinical and in clinical studies that intraventricular fibrinolysis (IVF) controls the phenomenon that are leading to DCI. Here, the investigators propose to conduct a phase III trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.

Description

Introduction: Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, which often causes acute hydrocephalus requiring the insertion of an external ventricular drain (EVD). A major complication of aneurysmal SAH is delayed cerebral ischemia (DCI), which corresponds to the occurrence of an ischemic stroke up to 21 days after the aneurysm rupture. There are currently only few ways to prevent it. As DCI is linked to the presence of blood within the subarachnoid space, it has been hypothesized that removing this blood may decrease the risk of DCI. It could be obtained by injecting a fibrinolytic agent through the EVD, a therapeutic strategy named intraventricular fibrinolysis (IVF). There are several evidences, both in preclinical and in clinical studies that IVF controls the phenomenon that are leading to DCI. It has notably been shown in Phase I and Phase II trial that IVF in aneurysmal SAH is safe and may decrease the risk of DCI, with a trend to improve the rate of good functional outcome by about 10%. Here, the investigators propose to conduct a phase III trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.

Materials and methods: this study will include patients with aneurysmal SAH requiring external ventricular drainage. The investigators will perform a pragmatic randomized controlled trial: compare the standard of care, i.e. the EVD alone, to the experimental treatment, i.e. IVF, with an open design. After exclusion of the aneurysm, patients will be randomly allocated to receive either EVD alone or EVD+IVF (72 hours, 9 doses). The primary outcome will be the proportion of patients without severe disability 6 months after the aneurysm rupture, as evaluated by the modified Rankin Scale (mRS). The investigators plan to include 440 patients, to show an increase of the rate of good functional outcome of 10% in the EVD+IVF group compared to the EVD alone group (=0.05 and =0.8). To obtain such sample, a multicenter trial is mandatory, and to date 16 centers accepted to participate. Each center will include one patient per month, and the inclusion period is to last 48 months.

Details
Condition Subarachnoid Hemorrhage
Treatment EVD + IVF with Alteplase
Clinical Study IdentifierNCT03187405
SponsorUniversity Hospital, Caen
Last Modified on4 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients (age 18-75) with SAH on initial CT-Scan examination
SAH associated with hydrocephalus requiring external ventricular drainage
Confirmation of an associated intracranial aneurysm by vascular imaging
Time from onset to admission under 24 hours
Exclusion of the aneurysm by surgical clipping or endovascular coiling before IVF
Oral information on research and informed consent of the patient and/or his relatives

Exclusion Criteria

Patient with severe clinical presentation on admission: WFNS score = 5
Associated intracerebral hematoma of more than 2 cm in its larger width
SAH diagnosed on lumbar puncture: original Fisher grade = 1
Impossibility to exclude the aneurysm within 72 hours following its rupture
Patient previously treated with antiplatelet therapy or treated with antiplatelet therapy after the aneurysm exclusion
Severe coagulopathy, including oral vitamin K antagonist
Pregnant or lactating woman
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note