Effects of HemaShock® use in normal volunteers on blood pressure (Fig 1) and amount of blood displaced from the legs to central circulation (Fig 2)
The HemaShock® was kept on each subject for 20 minutes.
Pre: Before HemaShock® Application
Dur: During HemaShock® Use
Post: After HemaShock® Removal
HemaShock® in Hemorrhagic Shock Cases
Preliminary clinical validation of HemaShock® in hemorrhagic shock cases was carried out at the Eisenhower Medical Center, Rancho Mirage, CA, USA.
HemaShock® was placed on 10 patients who presented to the ED, all in critical condition due to massive blood loss. It must be noted that the device was only placed within the hospital setting, and not, as intended, by EMS personnel, i.e. a delay that potentially influences the clinical outcome.
- 8 out of 10 patients responded to HemaShock® by immediately increasing BP
- 6 of those were stabilized and able to proceed to the next level of care
- 3 patients out of the 10 treated cases, were ultimately discharged home
The Figure below briefly summarizes these results.
Clinical Case: HemaShock® Use in an Elderly Woman in Severe Hemorrhagic Shock
An elderly woman was brought into the ED after being found down in bed by a relative. She had been complaining of stomach pain for several hours.
Paramedics found her to be unresponsive with BP less than 40 systolic, pale and ashen, with fixed dilated pupils. They assisted breathing and started lines, and transported her to the ED. Her abdomen was noted to be distended and firm.
Fluids were continued and blood brought rapidly to the ED. She was given 2 units of O negative cells, followed by three units of typed and cross-matched blood. After two liters of crystalloid, a Dopamine pressor drip was started. She had been intubated.
A CT with a contrast of the abdomen showed the abdomen full of blood and the contrast blushed in the area of the splenic artery suggesting a rupture. Thrombocytopenia was noted and she was given two platelet packs as well.
During this resuscitation, the systolic pressure was never able to get above 60mm.
At that point, the physician elected to try the HemaShock®. After rolling one device on each leg, the pressure immediately rose to 100 systolic. The dopamine was turned off and the patient was transferred to interventional radiology, where attempts to plug an aneurysm for two hours were unsuccessful.
At one time, the BP systolic went up to 140 and the tourniquets were rolled down to above the knees. The BP immediately dropped to 50 systolic, and the tourniquets were rolled back up, restoring the BP.
The patient was then taken to the OR where successful splenectomy and ligation of vessels performed.
Total tourniquet time was four and one-half hours on both legs. The patient survived and was discharged from the hospital 5 days later. She had a foot drop nerve injury in one leg that was likely a complication of the HemaShock® compression.
HemaShock® in Cardiac Arrest Cases
Preliminary clinical validation of the HemaShock® in cardiac arrest cases was carried out at the Eisenhower medical center, Rancho Mirage, CA, USA. HemaShock® was applied to 17 patients, presenting to the ED with cardiac arrest (Figure). All patients presented in critically end-stage status, having failed prehospital efforts including epinephrine, atropine, some amiodarone, and defibrillation, all presenting asystole or PEA rhythms, dilated pupils and essentially no vital signs. Once again, device placement was only carried out within a hospital Emergency Department, with significant time gap from the patients’ collapse to the application of HemaShock®.
7 out of the 17 cases experienced Return of Spontaneous Circulation (ROSC) within 1-5 minutes from HemaShock® application, and 1 patient was eventually discharged home in intact neurological status after brain protection (cooling) treatment in the ICU. Out of the remaining 6, 4 proceeded to brain preservation protocol but decease within 6-12 days, 2 patients were pronounced dead in the ED. No effect of HemaShock® was observed in 10 patients. Retrospective analysis showed that the HemaShock® application was not indicated (e.g. internal bleeding from cancer, extreme hyperthermia etc.).
Clinical Case: HemaShock® Use in Elderly Man in Circulatory Arrest
An elderly man collapsed at a restaurant. This elderly gentleman had an AICD in place that shocked him three times and each time he did not convert. The medics then arrived, started IVs and gave epi/amiodarone, and attempted to defibrillate 5 times unsuccessfully.
After 35 minutes of CPR, the patient arrived in the ED where HemaShock® devices were placed on both legs and within 2 minutes of additional CPR, the patient went into VF and was successfully cardioverted to ROSC. The rhythm degenerated into VF four more times until he was stabilized. We then started the hypothermia protocol, removed the devices gradually over the next 2 hours, and he was admitted to the ICU. Rewarming after 24 hours, which took a full 24 hours.
The patient appeared to be comatose for 7 days, but on the 8th day when weaned off the meds, he woke up and is neurologically intact with some probable diffuse slight ischemic encephalopathy. However, he is moving all extremities, speech is slow but clear, with some semblance of humor and he is recognizing his family.