Actively Recruiting

Age: 18Years +
All Genders
NCT06804421

Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.

Led by Fondazione IRCCS San Gerardo dei Tintori · Updated on 2025-02-03

1400

Participants Needed

33

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Recent studies state that patients affected by aneurysmal subarachnoid hemorrhage (aSAH) today survive longer because they are treated early. Unfortunately, patients often develop chronic disabling neurological deficits at a rate that is still unacceptable given the progress in the specific treatment of this pathology and the volume of systems of neurological monitoring available to date in Italy. The main cause of unfavorable neurological outcome is delayed cerebral ischemia (DCI), often resulting from symptomatic vasospasm defined as delayed neurological ischemic deficit (DIND). The incidence of DIND is not defined and is difficult to diagnose early as there is no gold standard for identifying it, nor guidelines regarding the most effective treatment. Given these gaps, the primary objective of this study is to describe the incidence of DIND in patients affected by aSAH, collecting information regarding the diagnostic imaging (neurological symptom on clinical examination or alteration on instrumental monitoring). Secondary objectives will be to evaluate the different therapeutic strategies adopted in the different participating centers and compare these strategies to mortality and short- and long-term functional neurological outcome. Furthermore, as there are no data in the literature, the Investigators want to describe the indications, usefulness and intensity of treatment in the aSAH patient in case of monitoring of parenchymal intracranial pressure.

CONDITIONS

Official Title

Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or angiography of the intracranial vessels
  • Need for admission to the Intensive Care Unit
  • Signing the Informed Consent form to participate in the study according to current local regulations.
Not Eligible

You will not qualify if you...

  • Age < 18 years
  • Primary diagnosis of subarachnoid hemorrhage sine materia, i.e. post-traumatic or caused by arteriovenous malformation or bleeding from a brain tumor.

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Trial Site Locations

Total: 33 locations

1

ASST Papa Giovanni XXIII

Bergamo, BG, Italy, 24127

Not Yet Recruiting

2

IRCCS Istituto delle Scienze Neurologiche

Bologna, BO, Italy, 40124

Not Yet Recruiting

3

ASST Spedali Civili

Brescia, BS, Italy, 25123

Not Yet Recruiting

4

Fondazione Poliambulanza

Brescia, BS, Italy, 25124

Not Yet Recruiting

5

ASST Lariana Ospedale Sant'Anna

San Fermo della Battaglia, CO, Italy, 22042

Not Yet Recruiting

6

ASST Cremona

Cremona, CR, Italy, 26100

Not Yet Recruiting

7

Azienda Ospedaliero-Universitaria Careggi

Florence, FI, Italy, 50134

Not Yet Recruiting

8

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy, 16132

Not Yet Recruiting

9

ASST Lecco - Ospedale A. Manzoni

Lecco, LC, Italy, 23900

Not Yet Recruiting

10

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy, 20900

Actively Recruiting

11

ASST Ovest Milanese - Ospedale di Legnano

Legnano, MI, Italy, 20025

Not Yet Recruiting

12

ASST Fatebenefratelli Sacco

Milan, MI, Italy, 20121

Not Yet Recruiting

13

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy, 20122

Not Yet Recruiting

14

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy, 20126

Not Yet Recruiting

15

ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

Milan, MI, Italy, 20153

Not Yet Recruiting

16

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, Italy, 20163

Not Yet Recruiting

17

Human Research Hospital

Rozzano, MI, Italy, 20089

Not Yet Recruiting

18

IRCCS San Raffaele

Segrate, MI, Italy, 20132

Not Yet Recruiting

19

ASST Mantova

Mantua, MN, Italy, 46100

Not Yet Recruiting

20

Azienda Ospedale-Università di Padova

Padova, PD, Italy, 35128

Not Yet Recruiting

21

Azienda Ospedaliera di Perugia

Perugia, PG, Italy, 06156

Not Yet Recruiting

22

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy, 43126

Not Yet Recruiting

23

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy, 27100

Not Yet Recruiting

24

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, Italy, 00152

Not Yet Recruiting

25

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, Italy, 00168

Not Yet Recruiting

26

ASST Valtellina e Alto Lario

Sondrio, SO, Italy, 23100

Not Yet Recruiting

27

ASL Città di Torino - Ospedale San Giovanni Bosco

Torino, TO, Italy, 10128

Not Yet Recruiting

28

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, Italy, 34128

Not Yet Recruiting

29

Azienda Sanitaria Universitaria Friuli Centrale

Udine, UD, Italy, 33100

Not Yet Recruiting

30

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, VA, Italy, 21100

Not Yet Recruiting

31

Ospedale San Bortolo

Vicenza, VI, Italy, 36100

Not Yet Recruiting

32

Azienda Ospedaliero Universitaria Integrata

Verona, VR, Italy, 37126

Not Yet Recruiting

33

AOU Maggiore della Carità

Novara, Italy, 28100

Not Yet Recruiting

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Research Team

G

Giuseppe Citerio, Professor, Head of Department

CONTACT

C

Clinical Research Coordination Office

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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