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| Name | Class |
|---|---|
| Far Eastern Memorial Hospital | OTHER |
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The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.
Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines. | |
| REBOA | Experimental | After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBOA | Device | Resuscitative endovascular balloon occlusion of the aorta (REBOA)is a device composed of a catheter attached to an inflatable balloon. It is inserted through the common femoral artery and guided to the thoracic aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved ROSC (return of spontaneous circulation) | Number of patients who achieves ROSC regardless of sustained time | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Sustained ROSC | Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes) | 24 hours |
| Survival to Admission | Whether patients who achieve sustained ROSC survives until admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Eun Kim | Contact | 82-31-787-7579 | hekim9111@gmail.com | |
| Dong Hyun Jang | Contact | 82-31-787-7819 | jang0621@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univeristy Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35870557 | Background | Jang DH, Lee DK, Jo YH, Park SM, Oh YT, Im CW. Resuscitative endovascular occlusion of the aorta (REBOA) as a mechanical method for increasing the coronary perfusion pressure in non-traumatic out-of-hospital cardiac arrest patients. Resuscitation. 2022 Oct;179:277-284. doi: 10.1016/j.resuscitation.2022.07.020. Epub 2022 Jul 21. | |
| 31707942 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 24, 2025 | Jan 24, 2025 | Prot_SAP_ICF_003.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 48 hours |
| Survival to Discharge | Whether patients survive until hospital discharge. | 30 days |
| Neurological Outcome | The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death. | 1 month, 3 months, 6 months since ROSC |
| Changes in Arterial Blood Pressure | Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used. | ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion. |
| Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11. |
| 35160193 | Background | Mazzoli CA, Chiarini V, Coniglio C, Lupi C, Tartaglione M, Gamberini L, Semeraro F, Gordini G. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Non-Traumatic Cardiac Arrest: A Narrative Review of Known and Potential Physiological Effects. J Clin Med. 2022 Jan 29;11(3):742. doi: 10.3390/jcm11030742. |
| 28117180 | Background | Daley J, Morrison JJ, Sather J, Hile L. The role of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to ACLS in non-traumatic cardiac arrest. Am J Emerg Med. 2017 May;35(5):731-736. doi: 10.1016/j.ajem.2017.01.010. Epub 2017 Jan 12. |
| 33145513 | Background | Nowadly CD, Johnson MA, Hoareau GL, Manning JE, Daley JI. The use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for non-traumatic cardiac arrest: A review. J Am Coll Emerg Physicians Open. 2020 Aug 30;1(5):737-743. doi: 10.1002/emp2.12241. eCollection 2020 Oct. |
| 34002305 | Background | Hutin A, Levy Y, Lidouren F, Kohlhauer M, Carli P, Ghaleh B, Lamhaut L, Tissier R. Resuscitative endovascular balloon occlusion of the aorta vs epinephrine in the treatment of non-traumatic cardiac arrest in swine. Ann Intensive Care. 2021 May 17;11(1):81. doi: 10.1186/s13613-021-00871-z. |
| 38347550 | Derived | Kim HE, Chu SE, Jo YH, Chiang WC, Jang DH, Chang CH, Oh SH, Chen HA, Park SM, Sun JT, Lee DK. Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial. Trials. 2024 Feb 13;25(1):118. doi: 10.1186/s13063-024-07928-x. |