A Phase 2 interventional study of Premarin IV and Placebo in Hemorrhagic Shock, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.
Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.
Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.
In spite of the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in hemorrhagic shock and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.
Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's enrollment of 50 is below the median of 77 across 540 interventional studies indexed under Shock.
Browse Shock studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Drug: Premarin IV
Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.
Drug: Placebo
One time dose of Premarin IV
Also known as: Estrogen IV
One time dose of placebo.
Also known as: Infuvite Multivitamin
Survival
Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.
Time frame: 28 Days
Acute Respiratory Distress Syndrome (ARDS) Free Survival
ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is \>10-14 days.
Time frame: 28 days
Clinical sites enrolled men and women age 18 to 55 who experienced hemorrhagic shock in the emergency medical services (EMS) setting between September 2009 and January 2012.
| Milestone | Premarin IV | Placebo |
|---|---|---|
| Started | 24 | 26 |
| Completed | 23 | 25 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Prisoner | 0 | 1 |
Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.
| participants | Premarin IV | Placebo |
|---|---|---|
| Survival | 16 | 21 |
ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is \>10-14 days.
| units on a scale | Premarin IV | Placebo |
|---|---|---|
| Acute Respiratory Distress Syndrome (ARDS) Free Survival | 3.00 ± 3.46 | 3.33 ± 3.01 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Premarin IV | — | 5/23 (21.7%) | 0/23 (0%) |
| Placebo | — | 7/25 (28%) | 0/25 (0%) |
| Event | Premarin IV | Placebo |
|---|---|---|
| Wound infectionInfections and infestations | 2/23 | 4/25 |
| Deep vein thrombosisVascular disorders | 2/23 | 0/25 |
| BloodstreamInfections and infestations | 1/23 | 0/25 |
| Urinary tract infectionInfections and infestations | 1/23 | 1/25 |
| Pseudomembranous colitisInfections and infestations | 1/23 | 0/25 |
| Pulmonary embolusVascular disorders | 1/23 | 1/25 |
| PneumoniaInfections and infestations | 0/23 | 1/25 |
| Line infectionInfections and infestations | 0/23 | 1/25 |
| Intra-abdominal abscessInfections and infestations | 0/23 | 1/25 |
| Age, Continuous(years) | Premarin IV | Placebo | Total |
|---|---|---|---|
| Mean | 33.9 (17 to 54) | 32.2 (20 to 56) | 33.0 (17 to 56) |
| Sex: Female, Male(Participants) | Premarin IV | Placebo | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 20 | 21 | 41 |
| Region of Enrollment(participants) | Premarin IV | Placebo | Total |
|---|---|---|---|
| United States | 23 | 25 | 48 |
Plan to share: No
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University of Texas Southwestern Medical Center