Implementing an Individualized Pain Plan (IPP) with Patient and Provider Electronic Health Record Access, for Adult Emergency Department Treatment of Vaso-occlusive Episodes in Sickle Cell Disease: A Pre-Post Study Design

Date Added
October 27th, 2020
PRO Number
Pro00097830
Researcher
Cathy Melvin

List of Studies


Keywords
Blood Disorders
Summary

Patients with Sickle Cell Disease (SCD) report numerous barriers to the receipt of timely and appropriate care in emergency department settings. One barrier is the lack of information available to providers to quickly assess and appropriately treat pain and other issues related to SCD. This project aims to embed an Individualized Pain Plan (IPP) in the electronic health record of each patient with SCD so that relevant information is readily available and care can be delivered more accurately and in a more timely manner.

Institution
MUSC
Recruitment Contact
Sarah Bourne
(843) 973-0095
bourne@musc.edu

A Phase 2, multicenter, randomized, placebo-controlled, doubleblind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment

Date Added
September 8th, 2020
PRO Number
Pro00098276
Researcher
Shayla Bergmann

List of Studies


Keywords
Blood Disorders
Summary

For patients with thrombotic thrombocytopenic purpura (aTTP), research involving SHP655 added to current standard of care treatment for aTTP may be effective by reducing the severity of TTP episodes, length time on therapy and reducing clinical complications of the disease. rADAMTS-13 is an essential protein that is inactivated by antibodies. The study drug, SHP655, is given by intravenous injection (IV). It is an essential synthetic protein used to replace decreased volumes of the rADAMTS-13 protein which will prevent or lessen the symptoms of aTTP. The study will last approximately 1.5 years with the Treatment phase occurring during hospitalization for the treatment of aTTP illness and the follow-up phase that will consist of study visits occurring every week for 4 visits, then biweekly for the 2 visits with a final completion visit 1 month after the last follow-up visit lasting for a 3-month period. The length of time for each visit should last approximately 2 hours. If a recurrence or relapse of aTTP occurs during the follow-up phase, subjects will not receive additional study drug, but subjects will be followed on a bi-weekly visit schedule until remission is achieved or 4 months after the initial remission, whichever is sooner.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

A Phase 1/2 randomized, double-blind, placebo-controlled, multicenter, ascending dose, safety and Pharmacokinetic/Pharmacodynamic PK/PD study of SHP655 (rADAMTS13) in sickle cell disease at baseline health and during acute vaso-occlusive crisis.

Date Added
August 25th, 2020
PRO Number
Pro00101087
Researcher
Shayla Bergmann

List of Studies


Keywords
Blood Disorders
Summary

Sickle cell disease (SCD) is a inherited disease that can cause sudden, severe pain. The management of this pain is accomplished through analgesic medications. This study for for male and female subjects between the ages of 18 and 65 years. This study will assess the appropriate dose and the evaluate the safety of SHP 655 in SCD patients at a baseline health state which is Part A of this study. The study medication is given by infusion as a single dose. SHP 655 is believed to increase blood flow and decrease blood cells from being trapped in low blood flow areas such as joints which can lead to tissue death.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

INTEGRATION OF mHEALTH INTO THE CARE OF PATIENTS WITH SICKLE CELL DISEASE TO INCREASE HYDROXYUREA UTILIZATION – mESH study

Date Added
July 23rd, 2020
PRO Number
Pro00097832
Researcher
Cathy Melvin

List of Studies


Keywords
Blood Disorders, Stroke, Stroke Recovery
Summary

The purpose of this research project is to evaluate the effectiveness of a mobile health (mHealth) application in improving adherence to hydroxyurea therapy in patients with Sickle Cell Disease (SCD). Participants will be asked to install an application on their phone that will remind them to take their medication regularly. It notifies the participants when it is time to request a refill, it tracks their hydroxyurea use, and it gives them information on their medication. It also has resources that could be helpful for the ongoing care of their sickle cell disease. This is a 24-week project with 3 study visits. The first study visit will be at the beginning of the study period (enrollment or baseline visit), the second will be at approximately 12 weeks, and the third is at the end of the 24 weeks. At each visit, participants will complete a survey, share with us their experience with the application, and share with us where they refilled their medications. Some participants will also be asked to complete an interview at the end of their final study visit. Patient participants will receive a $25 Walmart Gift card at each of visits (including an additional $25 gift card for the optional interview) for their participation.

Institution
MUSC
Recruitment Contact
Sarah Bourne
8433452545
bourne@musc.edu

Down syndrome biomarker project

Date Added
June 25th, 2020
PRO Number
Pro00090922
Researcher
Eric Hamlett

List of Studies


Keywords
Alzheimers, Blood Disorders, Brain, Children's Health, Dementia, Inflammation, Vascular
Summary

Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.

The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.

We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.

Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.

Institution
MUSC
Recruitment Contact
Eric Hamlett
919 357 7543
hamlette@musc.edu

A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (crizanlizumab), in Sickle Cell Disease Patients with Priapism (SPARTAN)

Date Added
February 11th, 2020
PRO Number
Pro00091529
Researcher
Shayla Bergmann

List of Studies


Keywords
Blood Disorders
Summary

This study is to evaluate the effectiveness of crizanlizumab-an monoclonal antibody on male patients between 16 to 65 years of age with Sickle cell disease experiencing vaso-occlusive crisis (VOC) priapism. The study will review the number of VOC-priapism events, their duration of the episodes and requirement of opioid treatment. Male patients may also take Hydroxyruea (HU) during study but must be receiving HU for at least 14 weeks before screening and continue HU during study.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System

Date Added
November 26th, 2019
PRO Number
Pro00089025
Researcher
Milos Budisavljevic

List of Studies


Keywords
Blood Disorders, Kidney
Summary

A device called the "Liposorber LA-15 System" has been approved by the
United States Food and Drug Administration for treating kids with focal
segmental glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used,
but the kidneys are still working okay. It can also be used if the subject
has had a kidney transplant and the FSGS comes back after the
transplant. Although the Liposorber System can be used for FSGS, we
are not sure how well the Liposorber System works. So, we are doing this
study to find out how well the treatment works in adults.
In this research study, there will be up to 5 adults who have FSGS
enrolled at MUSC. Subjects will come back for up to 12 treatments over 9
weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Date Added
September 24th, 2019
PRO Number
Pro00091452
Researcher
Charles Greenberg

List of Studies


Keywords
Blood Disorders
Summary

The purpose of this study is to test the safety and effectiveness of a new study drug in adults who have warm antibody autoimmune hemolytic anemia (wAIHA). This study aims to determine if participants receiving the study drug, called fostamatinib, respond better than participants receiving placebo (an inactive substance) measured by an increase in red blood cell count. Participation in the study will be for a duration of at least 30 weeks with a total of approximately 15 visits to the study clinic.

Institution
MUSC
Recruitment Contact
Ormarie Vazquez Silva
843-792-7333
vazquezo@musc.edu

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

Date Added
August 27th, 2019
PRO Number
Pro00091006
Researcher
Charles Greenberg

List of Studies


Keywords
Blood Disorders, Drug Studies
Summary

The purpose of this study is to evaluate the likely safety and effectiveness of danaparoid sodium versus argatroban for patients suffering from heparin-induced thrombocytopenia (HIT). Patients with HIT will have low blood platelet counts due to being given the medication heparin. Adult and pediatric participants who are determined to be eligible to participate will be assigned by chance to treatment with danaparoid sodium or argatroban. The study drugs are administered through intravenous therapy (IV). Study and safety assessments, including blood draws and compression ultrasounds, will be completed at study visits. Participants will be in this study for at least 45 days, but could receive treatment longer depending on HIT severity. You will be hospitalized while you are receiving study drug treatment for a minimum fo 14 days. You will have 4 study follow-up visits after they have been discharged from the hospital.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

SMYLS: A Self-Management Program for Youth Living with Sickle Cell Disease

Date Added
March 17th, 2019
PRO Number
Pro00084400
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Pain, Pediatrics
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens and young adults learning to care for and manage symptoms of their sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu



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