traumatic shock
Conditions
Interventions
Experimental group:REBOA operation with "life-saving balloon" + standard anti-shock treatment
Control group:Standard anti-shock treatment.
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Either gender, aged over 18 years old; 2. Patients with a main diagnosis of severe traumatic shock; 3. Family members are informed, sign the informed consent form and agree to participate in the trial; 4. Systolic blood pressure <= 80 mmHg or/and mean arterial pressure <= 60 mmHg, and the patient has non-compressible massive hemorrhage in the trunk and/or the pelvi-abdominal junction; 5. There is no obvious injury in the femoral artery or brachial artery, allowing the doctor to complete the arterial puncture or/and incision operation; 6. Whether the patient has ever been or is still receiving cardiopulmonary resuscitation; 7. Patients in shock who continue to receive resuscitative measures such as chest compressions and artificial respiration for more than 10 minutes, yet remain unresponsive or exhibit transient responsiveness followed by recurrent loss of consciousness;
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock and other non-traumatic shock; 2. Complicated with severe myocardial infarction, severe respiratory failure (type I or/and type II); 3. Severe craniocerebral trauma; 4. Definite bleeding of thoracic organs; 5. Subjects are participating in other drug or medical device clinical trials and have not yet completed the main research endpoints of that study; 6. Patients and their families refuse to enroll; 7. Patients who have been in shock and coma for over six hours upon arrival at the medical facility; 8. Other situations judged by the investigator as not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival status;whether Lower limb arterial embolism, thrombosis formation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate of balloon operation;in-hospital time length;event-free survival;blood pressure resuming time ;Secondary intervention rate;90-day postoperative survival rate??;72-hour resuscitation success rate; | — |
Countries
China
Contacts
Public ContactLu Qingsheng
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed