Head Trauma Clinical Trial
Official title:
Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique
isotonic NaCl serum is the first intent solution for infusion during the initial phase of
reanimation for an acute cranial traumatism.
However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious
for the future of this patient.
Isofundine present all charateristics to be use in this indication: pharmacokinetic and
pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose
provision and no interaction with hemostasis.
Participation in the study lasts 7 days per patient.
Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with
pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are
consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar
and without glucose. The study is an emergency: the resuscitation of a head injury, for
which the plasma by crystalloids may be delayed.
J0: Day of Inclusion
On arrival at the emergency operating room at the diagnosis of a serious head injury alone,
the anaesthetist that supports the patient in an initial phase includes the patient in the
study.
A H0, it is holding the patient randomization and continued his rehabilitation with the lot
of fluids allocated. If he wants to use macro-molecules, it may use
HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA:
witnesses arm includes saline solution and the HEAfusine while the interventional arm
includes Isofundine and tetraspan. These treatment are indistinguishable and both provided
by the laboratory Braun. They will be kept in operating emergency to be the most readily
available, upon arrival of the patient. If the health of the patient requires a refill
crystalloids emergency even before randomization did not take place, the clinician uses
originally Saline and starts the protocol as soon as possible as soon as the patient him can
take the few minutes needed to achieve inclusion. The first biological assessment include
the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the
lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in
Biological standard of care of a traumatized brain.
Apart from the contribution of crystalloids, the rest is therapeutic to the discretion of
clinicians. The indication of monitoring the intra-cranial pressure sensor
intra-parenchymatous is left to the discretion of the clinician without obligation
associated with the study. As requires the usual care of this pathology, the patient is then
transferred to intensive care.
J1 and J2
In accordance with the Memorandum of service, a basic daily infusion of crystalloids (30 ml
/ kg / day) is prescribed to all patients during the first 48 hours. The crystalloids used
for these basic inputs is the lot assigned at inclusion.
If the indications of plasma referred to by hemodynamic boli solutes remain free indication
of the doctor taking care of the patient, type of fluid used is the batch assigned to the
patient (Isofundine-Physiologic serum), including the use of macromolecules that are
available in the lot assigned to the patient (Heafusine-tetraspan).
Biological monitoring TBI usually based on a biological assessment every 12 hours. It
includes a ionograms blood and blood gases. On the same samples without extract a larger
volume of blood, we collect specifically in biological assessments:
- ionized calcium, magnesemia, natremia, kaliemia.
- lactatemia.
- albumin.
- plasma osmolarity. No blood gases.
Neurological based monitoring as requested by the clinician is changing the values of either
the PIC transcranial doppler.
The contribution of treatment under study stops at the 48th hour, after that time, the
inflow of fluid is pursued in accordance with the wishes of doctors, and the type of product
is imposed by the study .
J7 or exit resuscitation
The end of the study is the 7th day of inclusion (not trauma), or the day of release
resuscitation if it precedes the 7th day. This is the end of the collection of clinical data
and biological weapons. From J2-J7, no treatment and no record is imposed by the study. This
is a simple monitoring period assessing the future clinical neurological patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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