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Susan Mitchell
6 years ago
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University of Pittsburgh Departments of Critical Care and Emergency Medicine CONSENT TO ACT AS A SUBJECT IN A RESEARCH STUDY TITLE: CARDIAC ARREST BIOMARKER AND PHYSIOLOGY STUDY (CABAPS) Principal

edu Patrick Coppler (study coordinator) Jonathan Elmer, MD (secondary study coordinator) Clifton Callaway MD/PhD Ankur Doshi MD Frank Guyette MD Jon C Rittenberger MD/MS Lilian Emlet MD Sajid Kadir

1 University of Pittsburgh Departments of Critical Care and Emergency Medicine CONSENT TO ACT AS A SUBJECT IN A RESEARCH STUDY TITLE: CARDIAC ARREST BIOMARKER AND PHYSIOLOGY STUDY (CABAPS) Principal Investigator: Co-Investigators: Study Sponsor: Cameron Dezfulian, MD 3434 Hill Building Pittsburgh PA, Department of Critical Care Medicine Dezfulianc@upmc.edu Patrick Coppler (study coordinator) Jonathan Elmer, MD (secondary study coordinator) Clifton Callaway MD/PhD Ankur Doshi MD Frank Guyette MD Jon C Rittenberger MD/MS Lilian Emlet MD Sajid Kadir MD Hulya Bayir, MD Sruti Shiva PhD Matthew Murnin Peter Adams University of Pittsburgh School of Medicine Department of Critical Care Medicine Department of Emergency Medicine Purpose of the Study You or your loved one has suffered a cardiac arrest, a life threatening medical condition. Very little is known about the body s response to and the ways in which damage occur to the organs following a cardiac arrest. The Departments of Critical Care and Emergency Medicine are conducting a trial that is aimed at studying the body s response and ways in which injury occur after cardiac arrest. We plan to measure blood markers of circulation, metabolism, and the function of a subcellular organelle known as the mitochondria in the early hours and subsequent day after a cardiac arrest and correlate these markers with damage to the organs and the outcomes of cardiac arrest survivors. Study Procedures As part of this study, we are asking to use: 1) Information in your medical record Page 1 of 5

2 2) Blood collected in the intensive care unit 3) Use of monitors which will monitor oxygen and blood flow in the hand before, during and after we inflate a blood pressure cuff on the forearm to briefly stop blood flow to the hand. Study investigators may have already collected blood samples at ICU admission. Blood will be taken from an existing line when available at 0-3, 12-18, hours post arrest and at the day of intensive care discharge. The amount of blood drawn at each study time point is roughly 2 teaspoons and the total of all study blood draws will not exceed 10 teaspoons. Blood samples will be used to analyze markers of organ dysfunction. We will do a vaso-occlusion test at each study time point. The vaso-occlusion test consists of a blood pressure cuff on the forearm which is inflated to pressures higher than your blood pressure stopping blood flow for 5 minutes. A tissue oximetry device that measures oxygen saturation in the palm will be fixed to the area below your thumb and and a laser speckle camera which measures blood flow of the palm with be positioned above the hand. We will measure the rate at which oxygen and blood flow decrease when the cuff is inflated and revoers after it is deflated. In total we will make measures over approximately 20 minutes and the whole procedure should take 30 minutes at each time point. If you are found eligible for this research study and agree to be in this study, we will look at and write down information from your medical records. We want to keep track of general information about you, like your gender and age. All samples and data obtained from you will be assigned a number. We will keep a record of the number we assigned to you, but we will not give that number to anyone else. We will not give reports about the research we do to you or your doctor. We will not put the results in your medical record. The research results will not change the care you receive. We will also look at and write down information about your ambulance ride (if applicable) and your stay at UPMC immediately following this incident. We want to know about: your vital signs (pulse, breathing rate, weight, height) diagnoses doctors have given about your condition results of clinical lab tests medications you were given resuscitation efforts, which could include CPR, intubation, and IV transfusions. discharge location and neurological status at discharge Risk, Stress or Discomfort Risk of Blood Collection. There is minor risk of discomfort associated with the blood draws. If performed by venipuncture, it may cause bruising, bleeding, fainting, and rarely infection. Collection of blood from indwelling catheters (IV) could include clotting or malfunction of the catheter. This is the same risk as with any routine IV catheter placement. There is a risk of anemia with blood draws. To ensure this risk is minimal we will exclude you if your blood count (hemoglobin) is less than 8 grams per deciliter. By UPMC policy, we withhold blood transfusions usually until the blood count is below 7.5 so this cut off represents an effort to avoid putting you at additional risk for a transfusion. Risk of Vaso-occlusion Test. There is a minor risk of discomfort associated with the blood pressure cuff inflation. This includes numbness, tingling, and mild pain. If this occurs and is not tolerable by you, we will stop and not resume any procedures without your consent. Page 2 of 5

3 Confidentiality. We make every effort to keep the information about you confidential. You have been assigned a code number. This code number is used on all of the data we collected, including the blood samples. A key linking you to the code number is kept locked in a secure location and will be available only to the investigators. All patient identifiers (medical record number) will be removed from data within a year of the completion of the study. Laboratory samples will be destroyed as soon as analysis is complete. Data from this study, without your identity, may be reported in scientific meetings, articles or other appropriate communications. You will not be notified about the results of this study. Although we will make every effort to keep your information confidential, no system for protecting your confidentiality can be completely secure. It is possible that unauthorized persons might discover that you are in this study, or might obtain information about you. You will not be at greater risk than you are by being a patient in this hospital as we will use similar safeguards. University of Pittsburgh sometimes reviews studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm. In addition to the investigators listed on the front page of this consent form and their research staff, the following individuals may have access to identifiable information related to your participation in this research study: Authorized representatives of federal and local agencies providing oversight, including University of Pittsburgh Research Conduct and Compliance Office, who may review your identifiable research information (which may include your identifiable medical record information) for the purpose of monitoring the appropriate conduct of this research study. In unusual cases, the investigators may be required to release identifiable information (which may include your identifiable medical information) related to your participation in this research study in response to an order from a court of law. If the investigators learn that you or someone with whom you are involved is in serious danger or potential harm, they will need to inform, as required by Pennsylvania law, the appropriate agencies. Alternatives to taking part in this study Being in this study is voluntary. You do not have to be in this study if you don t want to be. You can stop at any time. Whether you choose to be in this study, or choose not to be in this study, will not affect your health care here at UPMC. Benefits of the study We hope that the results of this study will gain understanding of post-cardiac arrest physiology and lead us to novel therapeutic targets that will improve future patient care. Costs and Payments You or your loved one will not be paid for participating in this study. If you decide to not participate in this study, your doctor will continue to treat you or your loved one according to their usual standard of care treatment plan. You and your insurer or third party payer will not be billed for research-related services, such as services related solely to the research; study specific lab work will be paid for by the research grant. However, you, or your insurer, will be billed for all other usual care services, and/or services not connected with the study, just as you would if not in the study. No follow up is required for this study. No additional costs will be accrued due to participation in this study. Right to Withdraw If you decide to withdraw from this study, this decision will not affect either your current or future medical care at the University of Pittsburgh Medical Center. If you agree to participate and later change your mind, or if you later decide to withdraw, a written and dated notice of this decision needs to be sent to the investigator. All information and samples collected prior to your withdrawal will continue to be used. The investigators may Page 3 of 5

4 continue to use and disclose, for the purposes described above, identifiable information (which may include your identifiable medical information) related to your participation in this research study indefinitely. Please note that it is University policy that all research records must be maintained for at least 7 years following final reporting or publication of a project. You have the right to request that all information collected to date and/or the blood samples be destroyed. Voluntary Participation Your doctor may be involved as an investigator in this research study. As both your doctor and a research investigator, he is interested both in your medical care and the conduct of this research study. Before agreeing to participate in this research study, or at any time during your study participation, you may discuss your care with another doctor who is not associated with this research study. You are not under any obligation to participate in any research study offered by your doctor. Voluntary Consent The study has been described to me and all of my questions have been answered. Any additional questions or concerns about any aspect of this study will be answered by the researchers if questions, concerns or complaints arise. Questions I might have about my rights as a research participant will be answered by the Human Subject Protection Advocate at By signing this form, I agree to participate in this research study. A copy of this consent form will be given to me. Participant s Signature Printed Name of Participant Date/Time Surrogate Consent ******* is unable to provide direct consent for study participation because: Participant s Name (Print) Therefore, by signing this form, I give my consent for his/her participation in this research study. Representative s Name (Print) Representative s Signature Witness Signature if faxing or Electronic transfer Relationship to Participant Date/Time Date /Time Investigator s Certification Page 4 of 5

5 I certify that the nature and purpose, the potential benefits and possible risks associated with participation in this research study have been explained to the subject or their family member and any questions about this information have been answered. Investigator s Name (Print) Investigator s Signature Date/Time Consent for continued research participation: I understand that I am currently participating in a research study. Permission for my participation in this study was obtained initially through the exception from informed consent requirement or from my authorized representative (surrogate) because of my inability to provide consent when initial permission was requested. I have now recovered to the point where I feel that I can provide direct consent for continued participation in this research study. The study has been described to me and all of my questions have been answered. I understand that I have the right to request that all information collected to date and /or my blood samples be destroyed. Any additional questions or concerns about any aspect of this study will be answered by the researchers. Questions I might have about my rights as a research participant will be answered by the Human Subject Protection Advocate at By signing below, I agree to continue my participation in this research study. A copy of this consent form will be given to me. Participant s Signature Participant s Name (Print) Date/Time Investigator s Certification I certify that the nature and purpose, the potential benefits and possible risks associated with participation in this research study have been explained to the subject or their family member and any questions about this information have been answered. Investigator s Name (Print) Investigator s Signature Date/Time Page 5 of 5

University of Pittsburgh

University of Pittsburgh Department of Critical Care Medicine Consent to Participate in a Research Study of a Monitor Study Name: Research Directors: Augmented multimodal neurologic monitoring in high