A Prospective, Multi-centric, Randomized, Double-blind, Parallel, Saline Controlled Phase II Safety and Efficacy study of PMZ-2010 as a resuscitative agent for Hypovolemic Shock dueto excessive blood loss to be used along with standard shock treatment.

Pharmazz India Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2023年1月9日

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•a. Adult males or females aged 18-60 years.
•b.Patients with Hypovolemic shock due to blood loss admitted to the emergency room or ICU with systolic blood pressure <90 mmHg even after 10 min of standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors). Standard care to be provided to the patients shall be the one used in the particular hospital setup.
•c.Body weight 45 kg â?? 85 kg
•d. Estimated time from injury to randomization <4 hours
•e. Subject is <4 hours from time of Hypovolemic shock onset when the first dose of PMZ-2010 therapy is administered. Time of onset is when symptoms began; Reasonable expectation of availability to receive the full PMZ-2010 course of therapy, and to be available for subsequent follow-up visits
•f. Female subject is either:
•Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
•If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, or A vasectomised partner OR abstinence

•a. Terminal illness
•b. Development of any other terminal illness not associated with Hypovolemic shock during the 28 day observation period.
•c. Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) <= 8
•d. Type of injury is not known
•e. Inability to obtain intravenous access
•f.Known pregnancy
•g. Cardiopulmonary resuscitation (CPR) before randomization
•h. Presence of a do not resuscitate order
•i. Patient taking beta adrenergic antagonists
•j. Untreated tension pneumothorax
•k. Untreated cardiac tamponade
•l.Bilateral absent pupillary light reflex (both pupils fixed and dilated)
•m. Patient is participating in another interventional study
•n.Presence of systemic diseases (cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS)
•o.Patients with triad of coagulopathy, acidosis and hypothermia that requires immediate blood transfusion

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