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Enrollment was too slow with little potential for success. The complexities and resources needed for the intervention outweigh the very low probability of benefiting a rare patient. The DSMB and investigators agreed to terminate the study.
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| Name | Class |
|---|---|
| Cook County Health | OTHER_GOV |
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The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.
The intent of the technique to be studied is to induce a state of hypothermic preservation in trauma victims who have exsanguinated to the point of cardiac arrest. In appropriately selected subjects, after an initial emergency attempt at resuscitation with standard techniques, an arterial catheter will be inserted into the descending thoracic aorta. Using appropriate tubing, pump, and heat exchanger,a large quantity of ice-cold saline (0.9% Sodium Chloride for Injection USP) will be pumped as rapidly as possible into the aorta with the goal of cooling the brain (tympanic membrane temperature, Tty) to <10 C. If possible, a large venous catheter will be placed and recirculation of fluid established.
Once the subject has been sufficiently cooled, bleeding will be controlled surgically. The subject will then be resuscitated and rewarmed with full cardiopulmonary bypass.
The goal is to improve neurologically-intact survival in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent controls | Active Comparator | These subjects would undergo standard resuscitative efforts. |
|
| Emergency preservation and resuscitation | Experimental | These subjects would undergo the complete EPR protocol, including rapid induction of hypothermia, resuscitative surgery, and resuscitation with cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency preservation and resuscitation | Combination Product | This involves the induction of profound hypothermia using a flush of ice-cold saline into the aorta. Once hypothermia is achieved, the subject would undergo rapid operative interventions to control bleeding followed by resuscitation/rewarming with cardiopulmonary bypass. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is survival to hospital discharge without major disability (Glasgow Outcome Scale-Extended >5). | Hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of initiating EPR (cooling and achieving goal brain temperature) | 1 hour | |
| Survival | 28 days | |
| Neurologic functional outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel A Tisherman, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28538639 | Background | Tisherman SA, Alam HB, Rhee PM, Scalea TM, Drabek T, Forsythe RM, Kochanek PM. Development of the emergency preservation and resuscitation for cardiac arrest from trauma clinical trial. J Trauma Acute Care Surg. 2017 Nov;83(5):803-809. doi: 10.1097/TA.0000000000001585. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2016 | May 15, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006323 | Heart Arrest |
| D012771 | Shock, Hemorrhagic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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|
| Standard resuscitation | Other | Standard resuscitation includes an emergency department thoracotomy, open cardiac massage, and fluid resuscitation. |
|
| 12 months |
| Multiple organ system dysfunction | During the initial hospitalization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |