Échange de plasma pour les attaques aiguës sévères de la maladie démyélinisante inflammatoire
Plasma exchange
Maladies neuroinflammatoires+35
+ Troubles post-infectieux
+ Maladies Auto-immunes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1995
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately. The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges. The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges. Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment. Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed. Patients are followed at 1 and 6 months after the last exchange.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.22 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic inflammatory demyelinating syndrome, as follows: biopsy-proven if necessary - established diagnosis of multiple sclerosis (MS) using Poser criteria; acute disseminated encephalomyelitis; Marburg's variant of MS Balo's concentric sclerosis Eligible without biopsy: acute transverse myelitis; Devic's syndrome Acute neurologic deficit markedly affecting consciousness, language, or brainstem/spinal cord function, i.e., aphasia, paraplegia, coma, quadriplegia, hemiplegia, severe organic brain syndrome Deficit unresponsive to 5 days of high-dose intravenous methylprednisolone (MePRDL), as follows: deficit duration of 21 days to 3 months AND no improvement 14 days after beginning MePRDL OR deficit duration of 12 to 20 days AND continued deterioration after completion of MePRDL No chronically progressive demyelinating disease No HIV-associated demyelinating syndrome No progressive multifocal leukoencephalopathy No optic neuritis --Prior/Concurrent Therapy-- No more than 3 months of prior steroid therapy Failure on prior MePRDL required Minimum dose 7 mg/kg per day for 5 days At least 6 weeks since other immunosuppressives, e.g., cyclophosphamide, azathioprine, cyclosporine --Patient Characteristics-- Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No hypovolemia; no infarction; no vasculitis; no other major systemic cardiovascular illness Pulmonary: No major respiratory illness Other: No infection, including hepatitis or human immunodeficiency virus; no recent intravenous drug abuse; no high-risk sexual behavior; no cardiac, cerebrovascular, or autonomic dysfunction that would increase risk of hypotension; no other major systemic illness that would preclude protocol therapy; no pregnant or nursing women; negative serum pregnancy test required of fertile women; effective contraception required