Evaluating the safety of Administration of Adenosine, Lidocaine, and Mg(ALM) cocktail among Multiple Trauma Patients receiving Massive Transfusion with dose escalation A phase I, clinical trial

Determining the safety of Administration of Adenosine, Lidocaine, and Mg++(ALM) cocktail among Multiple Trauma Patients receiving Massive Transfusion and Admitted to the Resuscitation Room of Shahid Rajaee Trauma Hospital in Shiraz

a single-center, phase 1 trial , on 17 paitients, without control group

Eligible patients who transferred from the scene of trauma to resuscitation room will be treated with cocktail.

Eligible patients are between the ages of 16 and 60 who were transferred directly from the scene to the resuscitation room of Shahid Rajaei Trauma Hospital in Shiraz. Inclusion criteria will include patients who are candidates to receive a second bag of packed red blood cells. the paitients with severe underlying diseases (specially severe cardiac and pulmonary diseases and renal failure) ,and those who experienced slash thoracotomy, or if they have penetrating Traumatic brain injury or exposed brain matter. Also paitients with an irregular base ECG will be excluded from trial

The cocktail will be started in a group of 4 patients. if safety is confirmed the dose will be increased in next three patients.The ALM combination will be administered as the bolus and maintenance IV fluid. The maximom bolus dose of ALM IV injection consists of 200cc of normal saline,(87mg) of 2% Lidocaine, (6 mg) of adenosine and (30mg) of magnesium sulfate .The maximum dose of drip combination consists of 0.16 mg/kg/hr lidocaine, 0.19 mg/kg/hr Adenosine, and 0.2 mg/kg/hr MgSO4.Every drip component should be injected from separate bottle in 300 cc normal saline .

side effects;reduction in mortality ,hospitalizatin time ,amount of pack cell recieved

Due to the fact that the patients in the recovery room of the hospital usually receive up to 2 packs of blood and if needed, the rest of the blood is done in the inpatient departments or after transfer for better monitoring of the patients in the recovery room the criteria for inclusion in the study was changed instead of starting from the third pack to the second pack. Also, due to the lack of hypertonic saline, 3% of normal saline will be used in the blous dose. Also, due to the fact that people aged 16 to 18 are also considered as adult patients in the field of trauma, and due to the high prevalence of trauma incidents requiring transfusion in these people, they can benefit from this study. The minimum age for entering the study is 18 years. changed to 16 years. Also, considering the priority of investigating the effect of the cocktail on trauma patients receiving blood, and considering that most of the time such patients do not experience a severe drop in blood pressure or an increase in heart rate, and their injury severity criterion score is not necessarily more than 16; The condition of blood pressure below 70 or blood pressure below 90 with a heart rate of more than 108 was removed to enter the study, and the focus will be on patients receiving the second pack and beyond, regardless of pressure or heart rate. Also, the condition of injury severity criterion score of more than 16 to enter the study will be removed. Many critically ill patients with low blood pressure and heavy bleeding are transferred to the operating room after receiving a blood bag and receive subsequent blood bags in the operating room. These patients also benefit from this study, so patients with a systolic pressure below 80 who receive the first blood bag are also added to the conditions of entering the study