Clinical trial • Phase IV • Neurology|Other

MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE DIHYDRATE; SODIUM ACETATE TRIHYDRATE; SUCCINYLATED GELATIN for Neurosurgery

Phase IV trial of MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE DIHYDRATE; SODIUM ACETATE TRIHYDRATE; SUCCINYLATED…

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Neurosurgery
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-02-2024
First CTIS Authorization Date
11-06-2024

Trial design

Randomised Phase IV trial across 3 sites in Czechia.

Randomised
Yes
Target Sample Size
140

Eligibility

Recruits 140 Vulnerable population flag is selected in the trial record. Inclusion requires a signed informed consent form ("Signed the relevant informed consent form"). Subject information and informed consent form documents are provided in the dossier (NCHGDT_GDPR__V1_05032024; NCHGDT_ICF_pacient). No procedures for assent or surrogate consent for minors are specified; inclusion criterion requires age ≥ 18 years..

Pregnancy Exclusion
Pregnancy and lactation
Vulnerable Population
Vulnerable population flag is selected in the trial record. Inclusion requires a signed informed consent form ("Signed the relevant informed consent form"). Subject information and informed consent form documents are provided in the dossier (NCHGDT_GDPR__V1_05032024; NCHGDT_ICF_pacient). No procedures for assent or surrogate consent for minors are specified; inclusion criterion requires age ≥ 18 years.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Elective brain surgery with an expected duration ≥ 2 h"}
  • {"criterion_text":"- Category 1-3 according to the ASA Physical Status Classification"}
  • {"criterion_text":"- Lateral or supine operative position"}
  • {"criterion_text":"- Signed the relevant informed consent form"}

Exclusion criteria

  • {"criterion_text":"- Category 4 according to the ASA Physical Status Classification"}
  • {"criterion_text":"- Surgery for traumatic brain injury or acute hemorrhagic stroke"}
  • {"criterion_text":"- Awake brain surgery"}
  • {"criterion_text":"- Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)"}
  • {"criterion_text":"- Unavailability of hemodynamic monitoring data"}
  • {"criterion_text":"- Cardiac arrhythmia with irregular cardiac rhythm"}
  • {"criterion_text":"- Known hypersensitivity to the active substance or to any of the excipients of IMP"}
  • {"criterion_text":"- Pregnancy and lactation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Duration of surgery, LOS, ICU LOS, 28-day mortality, descriptive analysis of the incidence of any adverse events and reactions","definition_or_measurement_approach":""}
  • {"endpoint_text":"- MAP, HR, SVV, number of episodes of hypotension, number of vasopressor administrations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hemoglobin, plasma lactate level","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Volume of blood loss, urinary output, number of administered units of packed RBC, number of subjects receiving transfusion, crystalloid and colloid solutions consumption, boluses of crystalloids","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
140
Recruitment Window Months
39
Consent Approach
Participants must provide written informed consent (inclusion criterion: "Signed the relevant informed consent form"). Subject information and informed consent form documents are listed in the dossier (NCHGDT_GDPR__V1_05032024; NCHGDT_ICF_pacient). Consent is obtained from the participant (age requirement ≥ 18 years). Languages available are not specified in the record.

Geography

Total Number Of Sites
3
Total Number Of Participants
140

Czechia

Earliest CTIS Part Ii Submission Date
14-05-2024
Latest Decision Or Authorization Date
14-10-2025
Processing Time Days
518
Number Of Sites
3
Number Of Participants
140

Sites

Site Name
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Department Name
KARIM 1. LF UK a ÚVN
Contact Person Name
Tomáš Tyll
Contact Person Email
tomas.tyll@uvn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
KARIM FN Brno
Contact Person Name
Roman Gál
Contact Person Email
gal.roman@fnbrno.cz
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Oddělení anesteziologie, resuscitace a intenzivní medicíny
Contact Person Name
Tomáš Gabrhelík
Contact Person Email
Tomas.Gabrhelik@bnzlin.cz

Sponsor

Primary sponsor

Full Name
Fakultni Nemocnice Brno
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Czechia

Investigational products

Investigational Product Name
Gelaspan 4%, infuzní roztok
Active Substance
MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE DIHYDRATE; SODIUM ACETATE TRIHYDRATE; SUCCINYLATED GELATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
Max daily 3 l; max total 6 l
Investigational Product Name
Isolyte infuzní roztok
Active Substance
MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM ACETATE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Authorised
Maximum Dose
Max daily 3 l; max total 6 l

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