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Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Molar Sodium Lactate
physiological serum
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study.
  • Treated by endovascular embolization or surgically within 48 hours
  • After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma).
  • Affiliation to a social security system
  • After an adapted preliminary medical examination

Exclusion Criteria:

  • Post-traumatic meningeal hemorrhage
  • Management time >48h with respect to bleeding
  • Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease
  • Pregnant woman
  • Decision not to treat
  • Refusal to participate in the study
  • Adult patient protected by law
  • Person deprived of administrative or judicial freedom

Sites / Locations

  • Grenoble Hospital
  • Marseille Hospital
  • Nice Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Molar Sodium Lactate

physiological serum

Arm Description

Outcomes

Primary Outcome Measures

median transit time (MTT)
median transit time (MTT) in seconds, on the perfusion scanner on 6 regions of the brain between D0 and D7 of the product perfusion

Secondary Outcome Measures

Full Information

First Posted
October 25, 2019
Last Updated
October 25, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04141371
Brief Title
Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage
Official Title
Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective. In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view. The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid. This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
paticipant and radiologists are masked
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Molar Sodium Lactate
Arm Type
Active Comparator
Arm Title
physiological serum
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Molar Sodium Lactate
Intervention Description
daily 3-hour infusion of sodium molar lactate during the vasospasm period
Intervention Type
Drug
Intervention Name(s)
physiological serum
Intervention Description
daily saline infusion over 3 hours during the vasospasm period
Primary Outcome Measure Information:
Title
median transit time (MTT)
Description
median transit time (MTT) in seconds, on the perfusion scanner on 6 regions of the brain between D0 and D7 of the product perfusion
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study. Treated by endovascular embolization or surgically within 48 hours After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma). Affiliation to a social security system After an adapted preliminary medical examination Exclusion Criteria: Post-traumatic meningeal hemorrhage Management time >48h with respect to bleeding Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease Pregnant woman Decision not to treat Refusal to participate in the study Adult patient protected by law Person deprived of administrative or judicial freedom
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
herve quintard, ph
Phone
33492037777
Email
quintard.h@chu-nice.fr
Facility Information:
Facility Name
Grenoble Hospital
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jean francois payen, puph
Phone
33476766890
First Name & Middle Initial & Last Name & Degree
jean francois payen
Facility Name
Marseille Hospital
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lionel velly, ph
Phone
33491324053
First Name & Middle Initial & Last Name & Degree
lionel velly, ph
Facility Name
Nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
herve quintard, PH
Email
quintard.h@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
herve quintard, ph
First Name & Middle Initial & Last Name & Degree
carole ichai, PUPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

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