| ID | Type | Description | Link |
|---|---|---|---|
| R44HL065851-03 | U.S. NIH Grant/Contract | View source | |
| 2R44HL065851-03 | U.S. NIH Grant/Contract | View source | |
| 43-0303-000 |
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Terminated due to lack of funding. Follow-up completed for all enrolled subjects.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic recovery and survival to hospital discharge following out-of-hospital cardiac arrest.
Despite receiving conventional, standard CPR (S-CPR), most patients who experience out-of-hospital cardiac arrest die prior to arriving at a hospital. At the present time, the hospital discharge rate following out-of-hospital, nontraumatic cardiac arrest in adults in the United States is estimated to be less than 5%. Many factors contribute to the current poor survival statistics, including the inefficiency of the technique itself. CPR provides only 10% to 20% of normal myocardial perfusion, and only 20% to 30% of physiologically normal cerebral perfusion.
A new method of CPR that combines ACD and an ITD (ACD-CPR+ITD) has been shown in animal models and in clinical trials conducted in Europe to provide significantly more blood flow to the vital organs and to improve survival rates when compared to S-CPR or ACD-CPR alone.
ACD-CPR+ITD works by decreasing intrathoracic pressure during the chest wall recoil (or decompression) phase of CPR, creating a vacuum within the thorax relative to the rest of the body. When compared with controls, use of ACD-CPR+ITD (a) enhances blood return to the thorax during the chest wall recoil phase, (b) enhances blood flow to the heart and brain, (c) provides real-time feedback to rescuers to maintain high-quality CPR, (d) improves overall CPR efficiency and, as a result of the forgoing, (e) improves short-term survival rates.
The sponsor and others recently evaluated the effectiveness of the combination of conventional, manual standard CPR±ITD in animals and humans. The ITD increased short-term survival rates in these studies as well. Two clinical trials were performed in Milwaukee, Wisconsin, under IDE (#G980125). Both compared S-CPR with either a sham (nonfunctional or placebo) or active (functional) ITD. The results from the hemodynamic study demonstrated that systolic blood pressure, the primary end point, increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD (P less than 0.05). Intensive care unit admission rate was the primary end point of the clinical outcome study.
Comparisons: The objective of this two-arm, multisite, randomized, pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR compared to ACD-CPR+ITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) |
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| 2 | Active Comparator | Conventional standard cardiopulmonary resuscitation (S-CPR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) | Device | The ITD selectively prevents the influx of unnecessary respiratory gases into the patient during the chest wall recoil phase of CPR. The ResQPump, a hand-held device containing a suction cup, attaches to the chest and actively compresses and actively re-expands the chest during the performance of CPR. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 | favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention. | When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events | Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith G. Lurie, MD | Advanced Circulatory Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 07: Indianapolis, IN | Indianapolis | Indiana | 46202 | United States | ||
| Site 06: Washtenaw & Livingston Counties, MI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14568898 | Background | Wolcke BB, Mauer DK, Schoefmann MF, Teichmann H, Provo TA, Lindner KH, Dick WF, Aeppli D, Lurie KG. Comparison of standard cardiopulmonary resuscitation versus the combination of active compression-decompression cardiopulmonary resuscitation and an inspiratory impedance threshold device for out-of-hospital cardiac arrest. Circulation. 2003 Nov 4;108(18):2201-5. doi: 10.1161/01.CIR.0000095787.99180.B5. Epub 2003 Oct 20. | |
| 9054757 | Background |
| Label | URL |
|---|---|
| Sponsor: Advanced Circulatory Systems, Inc. home page | View source |
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All sites were required to complete a run-in phase prior to to beginning randomization. A total of 2667 patients (197 run-in, 2470 pivotal) were provisionally enrolled and received randomized CPR treatment. Of these, 1653 pivotal patients met the final selection criteria (non-traumatic arrest due to cardiac cause).
The study was conducted under a waiver of informed consent for emergency research that was approved by the U.S. Food and Drug Administration and by the Institutional Review Boards at participating study sites. All adults with out-of-hospital cardiac arrest were eligible for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard CPR | Conventional standard cardiopulmonary resuscitation (S-CPR) |
| FG001 | ACD CPR Plus ITD | Active compression decompression CPR plus an Impedance Threshold Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard cardiopulmonary resuscitation (S-CPR) | Procedure | Conventional standard cardiopulmonary resuscitation (S-CPR) |
|
| Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge |
| Return of Spontaneous Circulation (ROSC) | Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS. | Time of cardiac arrest until discontinuation of efforts |
| Survival to Hospital (e.g., Intensive Care Unit) Admission | Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest. | Time of hospital admission, up to 1 day after cardiac arrest |
| Survival to 24 Hours | Number of patients who were alive 24 hours after the initial cardiac arrest. | 24 hours following cardiac arrest |
| Survival to Hospital Discharge | cardiac arrest to hospital discharge |
| Survival to 90 Days | Number of patients who are known to be alive 90 days after the index cardiac arrest. | 90 days following cardiac arrest |
| Survival to 365 Days | Number of patients who are alive 365 days after the index cardiac arrest. | 365 days following cardiac arrest |
| Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)] | CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores. | One year after index arrest |
| Ann Arbor |
| Michigan |
| 48106 |
| United States |
| Site 04: Oakland & Macomb Counties, MI | Royal Oak | Michigan | 48073 | United States |
| Site 02: Minneapolis, MN | Minneapolis | Minnesota | 55415 | United States |
| Site 01: St. Paul, MN | Saint Paul | Minnesota | 55101 | United States |
| Site 03: Whatcom County, WA | Bellingham | Washington | 98225 | United States |
| Site 05: Oshkosh, WI | Oshkosh | Wisconsin | 54901 | United States |
| Plaisance P, Adnet F, Vicaut E, Hennequin B, Magne P, Prudhomme C, Lambert Y, Cantineau JP, Leopold C, Ferracci C, Gizzi M, Payen D. Benefit of active compression-decompression cardiopulmonary resuscitation as a prehospital advanced cardiac life support. A randomized multicenter study. Circulation. 1997 Feb 18;95(4):955-61. doi: 10.1161/01.cir.95.4.955. |
| 15891326 | Background | Plaisance P, Soleil C, Lurie KG, Vicaut E, Ducros L, Payen D. Use of an inspiratory impedance threshold device on a facemask and endotracheal tube to reduce intrathoracic pressures during the decompression phase of active compression-decompression cardiopulmonary resuscitation. Crit Care Med. 2005 May;33(5):990-4. doi: 10.1097/01.ccm.0000163235.18990.f6. |
| 15172704 | Background | Plaisance P, Lurie KG, Vicaut E, Martin D, Gueugniaud PY, Petit JL, Payen D. Evaluation of an impedance threshold device in patients receiving active compression-decompression cardiopulmonary resuscitation for out of hospital cardiac arrest. Resuscitation. 2004 Jun;61(3):265-71. doi: 10.1016/j.resuscitation.2004.01.032. |
| 11273935 | Background | Voelckel WG, Lurie KG, Zielinski T, McKnite S, Plaisance P, Wenzel V, Lindner KH. The effects of positive end-expiratory pressure during active compression decompression cardiopulmonary resuscitation with the inspiratory threshold valve. Anesth Analg. 2001 Apr;92(4):967-74. doi: 10.1097/00000539-200104000-00032. |
| 10451462 | Background | Plaisance P, Lurie KG, Vicaut E, Adnet F, Petit JL, Epain D, Ecollan P, Gruat R, Cavagna P, Biens J, Payen D. A comparison of standard cardiopulmonary resuscitation and active compression-decompression resuscitation for out-of-hospital cardiac arrest. French Active Compression-Decompression Cardiopulmonary Resuscitation Study Group. N Engl J Med. 1999 Aug 19;341(8):569-75. doi: 10.1056/NEJM199908193410804. |
| 8923582 | Background | Schneider T, Wik L, Baubin M, Dirks B, Ellinger K, Gisch T, Haghfelt T, Plaisance P, Vandemheen K. Active compression-decompression cardiopulmonary resuscitation--instructor and student manual for teaching and training. Part I: The workshop. Resuscitation. 1996 Oct;32(3):203-6. doi: 10.1016/0300-9572(96)00946-x. |
| 8923583 | Background | Wik L, Schneider T, Baubin M, Dirks B, Ellinger K, Gisch T, Haghfelt T, Plaisance P, Vandemheen K. Active compression-decompression cardiopulmonary resuscitation--instructor and student manual for teaching and training. Part II: A student and instructor manual. Resuscitation. 1996 Oct;32(3):206-12. doi: 10.1016/0300-9572(96)82051-x. No abstract available. |
| 10825624 | Background | Lurie K, Voelckel W, Plaisance P, Zielinski T, McKnite S, Kor D, Sugiyama A, Sukhum P. Use of an inspiratory impedance threshold valve during cardiopulmonary resuscitation: a progress report. Resuscitation. 2000 May;44(3):219-30. doi: 10.1016/s0300-9572(00)00160-x. |
| 10704165 | Background | Plaisance P, Lurie KG, Payen D. Inspiratory impedance during active compression-decompression cardiopulmonary resuscitation: a randomized evaluation in patients in cardiac arrest. Circulation. 2000 Mar 7;101(9):989-94. doi: 10.1161/01.cir.101.9.989. |
| 10507710 | Background | Mauer DK, Nolan J, Plaisance P, Sitter H, Benoit H, Stiell IG, Sofianos E, Keiding N, Lurie KG. Effect of active compression-decompression resuscitation (ACD-CPR) on survival: a combined analysis using individual patient data. Resuscitation. 1999 Aug;41(3):249-56. doi: 10.1016/s0300-9572(99)00073-8. |
| 15993724 | Background | Pirrallo RG, Aufderheide TP, Provo TA, Lurie KG. Effect of an inspiratory impedance threshold device on hemodynamics during conventional manual cardiopulmonary resuscitation. Resuscitation. 2005 Jul;66(1):13-20. doi: 10.1016/j.resuscitation.2004.12.027. |
| 15818098 | Background | Aufderheide TP, Pirrallo RG, Provo TA, Lurie KG. Clinical evaluation of an inspiratory impedance threshold device during standard cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest. Crit Care Med. 2005 Apr;33(4):734-40. doi: 10.1097/01.ccm.0000155909.09061.12. |
| 11772887 | Background | Lurie KG, Zielinski T, McKnite S, Aufderheide T, Voelckel W. Use of an inspiratory impedance valve improves neurologically intact survival in a porcine model of ventricular fibrillation. Circulation. 2002 Jan 1;105(1):124-9. doi: 10.1161/hc0102.101391. |
| 11801347 | Background | Langhelle A, Stromme T, Sunde K, Wik L, Nicolaysen G, Steen PA. Inspiratory impedance threshold valve during CPR. Resuscitation. 2002 Jan;52(1):39-48. doi: 10.1016/s0300-9572(01)00442-7. |
| 15081185 | Background | Yannopoulos D, Sigurdsson G, McKnite S, Benditt D, Lurie KG. Reducing ventilation frequency combined with an inspiratory impedance device improves CPR efficiency in swine model of cardiac arrest. Resuscitation. 2004 Apr;61(1):75-82. doi: 10.1016/j.resuscitation.2003.12.006. |
| 12456407 | Background | Raedler C, Voelckel WG, Wenzel V, Bahlmann L, Baumeier W, Schmittinger CA, Herff H, Krismer AC, Lindner KH, Lurie KG. Vasopressor response in a porcine model of hypothermic cardiac arrest is improved with active compression-decompression cardiopulmonary resuscitation using the inspiratory impedance threshold valve. Anesth Analg. 2002 Dec;95(6):1496-502, table of contents. doi: 10.1097/00000539-200212000-00007. |
| 15166836 | Background | Frascone RJ, Bitz D, Lurie K. Combination of active compression decompression cardiopulmonary resuscitation and the inspiratory impedance threshold device: state of the art. Curr Opin Crit Care. 2004 Jun;10(3):193-201. doi: 10.1097/01.ccx.0000126089.40242.a9. |
| 8176802 | Background | Lurie KG, Shultz JJ, Callaham ML, Schwab TM, Gisch T, Rector T, Frascone RJ, Long L. Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest. JAMA. 1994 May 11;271(18):1405-11. |
| 11919340 | Background | Voelckel WG, Lurie KG, Sweeney M, McKnite S, Zielinski T, Lindstrom P, Peterson C, Wenzel V, Lindner KH. Effects of active compression-decompression cardiopulmonary resuscitation with the inspiratory threshold valve in a young porcine model of cardiac arrest. Pediatr Res. 2002 Apr;51(4):523-7. doi: 10.1203/00006450-200204000-00020. |
| 21251705 | Result | Aufderheide TP, Frascone RJ, Wayne MA, Mahoney BD, Swor RA, Domeier RM, Olinger ML, Holcomb RG, Tupper DE, Yannopoulos D, Lurie KG. Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial. Lancet. 2011 Jan 22;377(9762):301-11. doi: 10.1016/S0140-6736(10)62103-4. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard CPR | Conventional standard cardiopulmonary resuscitation (S-CPR) |
| BG001 | ACD CPR Plus ITD | Active compression decompression CPR plus an Impedance Threshold Device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 | favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention. | The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria. | Posted | Number | patients | When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge |
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| Secondary | Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events | Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury. | Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria. | Posted | Number | patients | Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge |
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| Secondary | Return of Spontaneous Circulation (ROSC) | Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS. | Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria. | Posted | Number | patients | Time of cardiac arrest until discontinuation of efforts |
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| Secondary | Survival to Hospital (e.g., Intensive Care Unit) Admission | Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest. | Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria. | Posted | Number | patients | Time of hospital admission, up to 1 day after cardiac arrest |
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| Secondary | Survival to 24 Hours | Number of patients who were alive 24 hours after the initial cardiac arrest. | Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria. | Posted | Number | patients | 24 hours following cardiac arrest |
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| Secondary | Survival to Hospital Discharge | Posted | Number | patients | cardiac arrest to hospital discharge |
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| Secondary | Survival to 90 Days | Number of patients who are known to be alive 90 days after the index cardiac arrest. | Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria. | Posted | Number | patients | 90 days following cardiac arrest |
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| Secondary | Survival to 365 Days | Number of patients who are alive 365 days after the index cardiac arrest. | Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria. | Posted | Number | patients | 365 days following cardiac arrest |
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| Secondary | Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)] | CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores. | Posted | Mean | Standard Deviation | units on a scale | One year after index arrest |
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Through hospital discharge, up to 30 days after index arrest.
Only serious adverse events were assessed for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard CPR | Conventional standard cardiopulmonary resuscitation (S-CPR) | 766 | 813 | 0 | 0 | ||
| EG001 | ACD CPR Plus ITD | Active compression decompression CPR plus an Impedance Threshold Device | 787 | 840 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Systematic Assessment |
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| re-arrest | General disorders | Systematic Assessment |
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| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| seizure | General disorders | Systematic Assessment |
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| bleeding requiring intervention | General disorders | Systematic Assessment |
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| rib/sterna fracture | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| cerebral bleeding | General disorders | Systematic Assessment |
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| internal organ injury | General disorders | Systematic Assessment |
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| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Advanced Circulatory Systems, Inc. | 651-403-5600 | csetum@advancedcirculatory.com |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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