Use of Levosimendan as treatment of aneurysmal Hemorrhage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Physiological processes [G07]

Trial duration

4 Nov 2024 → ongoing

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514242-36-00

EudraCT number

2021-001702-30

ClinicalTrials.gov

NCT05664191

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the efficacy of levosimendan in patients admitted to intensive
care for HSAa at high risk of ASV (WFNS Grade I to IV and Fisher score 3 or 4) on the occurrence of ASV.

Secondary objectives 5

1. evaluate the effects of treatment with Levosimendan on: mortality on D14, D28 and D90; the occurrence of ICD within 14 days of the bleeding.
2. Assess the effects of levosimendan treatment on mRS at 3 months
3. Assessment of the effects of levosimendan treatment on cardiac dysfunction
4. Evaluation of the effects of levosimendan treatment on cerebral perfusion
5. Assessment of the effects of treatment with levosimendan on the length of stay in intensive care

Conditions and MedDRA coding

subarachnoid hemorrhages of aneurysmal origin (HSAa)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. All adult patients (≥ 18 to 75),
2. hospitalized in surgical intensive care at Lariboisière for subarachnoid hemorrhage of aneurysm origin
3. (HSAa) clinical score WFNS I to IV and Fisher score 3 or 4.

Exclusion criteria 7

1. Contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension, tachycardia, cardiac mechanical obstructions)
2. severe renal impairment (creatinine clearance <30 ml / min)
3. Severe hepatic insufficiency (signs of hepatic encephalopathy);
4. History of torsades de pointes
5. Severe pre-existing neuro-vascular pathologies
6. Moribund patients.
7. pregnant women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the occurrence of cerebral arterial vasospasm within 14 days of the bleeding

Secondary endpoints 3

1. the cumulative incidence of death rate, ICDs and vasospasms
2. The mRS score at 6 months
3. Impact of Levosimendan treatment on cardiac dysfunction

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications