Clinical Trials

 

Title	A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting (PolyHeme)
Purpose	The purpose of this study is to evaluate the safety and effectiveness of Poly SFH-P Injection (PolyHeme), an experimental (investigational) blood substitute, in treating shock (low blood pressure) following blood loss from traumatic injury. The effect of the test article will also be assessed in reducing the use of uncrossmatched blood; the use of allogeneic blood; incidence of multi-organ system failure; day 1 and day 30 mortality; to compare the groups with respect to serious adverse events.
Study Number	100292
Number of Patients	720
Eligibility	A person may be enrolled into the study if they are 18 years of age or older, have sustained either blunt or penetrating trauma, demonstrate evidence of blood loss due to the injury and have a systolic blood pressure less than 90.  They will be enrolled and randomized into the study by trained EMS before arrival to the hospital.  A patient will be excluded from this study if they object to the study or object to receiving blood products or are wearing a bracelet which states “I Decline the Northfield PolyHeme Study”.  Patients will also be excluded from the study if death is thought to be imminent, their GCS ? 5, they are asystolic or requiring CPR, they have received more than 1000 ml of crystalloid, are suspected to be pregnant, or have a DNR order.
Treatment	1.  Control group. In the pre-hospital setting, IV fluids are started for hemorrhagic shock following traumatic injury. Upon arrival to hospital patients will receive saline. If in the control group and a decision is made to give a blood transfusion in the first 12-hours of care, they will receive donated blood. After 12 hours, donated blood will be used. 2.  The experimental group will receive Poly SFH-P Injection (PolyHeme) and then saline at the hospital. If in the experimental group and a decision is made to give a blood transfusion in the first 12-hours of care, they will receive a unit of Poly SFH-P Injection (PolyHeme) up to a total of 6 units. If in need of blood transfused after receiving 6 units of Poly SFH-P Injection (PolyHeme), donated blood will be given. After the 12-hour period, donated blood will be given.
Principal Investigator	Richard L. Gamelli, MD
Enrollment Phone	708 327-2452
Title	Inflammation and the Host Response to Injury - Burn Patients with >=20% TBSA Burns and Inflammation and the Host Response to Injury - Burn Tissue Repository Study (Glue Grant)
Purpose	With this NIH funded grant multiple burn and trauma units around the country are “glued” together for research: 1.  To determine how people respond differently to burn injury in terms of living and dying and such things as wound healing. 2.  Identify different responses of the proteins and genes in the blood, muscle, fat, skin, and scar after burn injury that correspond to how people respond differently  The long-term goal of this research is to increase understanding of the complex problem of the systemic inflammatory response syndrome (SIRS) and the often accompanying multiple organ dysfunction syndrome (MODS) observed in patients after trauma and burn injury.  Traumatic injury, SIRS, and MODS are recognized as continuing significant health problems, and thus this application has a high degree of clinical relevance.  Currently there is no integrative paradigm or conceptual model that can be tested based on inflammatory phenotypes and genetic markers; this void would be filled by the studies proposed in this protocol.  Successful completion of this work would be expected to provide novel information that could be used to determine a patient's location on a particular clinical path and to better predict the clinical course of the patient's recovery.  Armed with this knowledge, it may be possible to more effectively treat patients in a more timely manner, thereby limiting morbidity and mortality.
Study Number	106609
Number of Patients	350
Eligibility	A person may be enrolled into the study if they are 18 years of age or older, have sustained a burn ? 20% TBSA and will require at least one surgery for skin grafting and sign a study consent.  Patients will be excluded from the study if they have a chemical or electrical burn, anoxic brain injury that is not expected to result in complete recovery, have an ISS ?25, or have a pre-morbid condition of CHF, Malignancy, require glucocorticoid treatment or require systemic immunosuppression.
Treatment	1. Draw a blood sample upon admission to the hospital and weekly while in the ICU.  2. Draw a blood sample just prior to each surgery for skin grafting. 3. During each surgery for skin grafting if deep burns are present small samples of fat and/or muscle may be collected. 4. During each surgery for skin grafting a sample of the skin will be collected.  5. If reconstructive surgery occurs within two years of burn injury a blood sample and the same samples taken of the muscle, fat, and donor skin, as well as an additional sample of the scar that is removed will be collected. The blood and fluids will be used for proteomics and genomics. Cytokine levels will be assayed. All of this will be done off-site.
Principal Investigator	Richard L. Gamelli, MD
Enrollment Phone	708 327-2457
Title	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Recombinant Human Erythropoietin (epoetin alfa; PROCRIT) on Functional Outcomes in Anemic, Critically Ill, Trauma Subjects (Procrit)
Purpose	The primary objective of this trial is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with PROCRIT® (epoetin alfa) compared to placebo. The secondary objectives include evaluation of functional independence, evaluation of Health Related Quality of Life, time to hemoglobin (Hg) response, Hb change over time and evaluation of return to usual activities, neurocognitive function, and time on mechanical ventilation.
Study Number	107934
Number of Patients	200
Eligibility	A person may be enrolled into the study if they are 18 – 55 years of age, have a Hgb ? 12, have an expected ICU or intermediate care stay ? 2 days secondary to a blunt multi-system traumatic injury which includes a lower extremity long bone or pelvic fracture, had the ability to function independently prior to this hospitalization, GCS ?13 within 24 hours of hospital admission and sign a study consent.  Patients will be excluded from this study if they have an acute burn, GCS ? 12, a spinal cord injury, injury was secondary to a fall from standing position, they were transferred ?8 hours after injury, are not expected to survive 12 months given their injuries and/or pre-existing medical conditions, significant preexsisting disease, uncontrolled hypertension, new onset seizures, history of DVT, refusal to accept blood transfusion, known hypersensitivity to albumin or mammalian cell derived products or epoetin alfa.
Treatment	1.  Study drug (PROCRIT or matching placebo) will be administered weekly by SC injection both in the hospital and for a maximum of 12 weeks after hospital discharge. 2.  Blood samples will be obtained upon admission, weekly while in the ICU and upon hospital discharge or study withdrawal. 3.  H&H weekly from day of hospital discharge for discharge weeks 1-12 and then at 16, 20, 24 weeks and at study withdrawal. 4.  Serum Iron Panel upon admission, hospital discharge week 1 and withdrawal from the study. 5.  DNA sample at discharge week 12 if patient signs additional consent.
Principal Investigator	Fred A. Luchette, MD
Enrollment Phone	708 327-2457
Title	A multi-center, randomized, double-blind, parallel group, placebo controlled trial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven®/NiaStase®) in the treatment of refractory bleeding in severely injured trauma patients F7Trauma-1648.  (Factor VII)
Purpose	The primary objective of the trial is to evaluate the efficacy and safety of rFVIIa (NovoSeven®/NiaStase®) as an adjunct to standard treatment of trauma patients with active hemorrhage refractory to blood component therapy and surgical hemostatic procedures.
Study Number	108805
Number of Patients	1502
Eligibility	A person may be enrolled into the study if they are between 18 –65 years of age and sustained blunt and/or penetrating trauma with evidence of active torso hemorrhage refractory to blood component therapy and surgical hemostatic procedures and have received a minimum of 4 units of RBC and before the completion of the 8th unit of RBC and sign a study consent.  A patient will be excluded from the study if condition is moribund, they have evidence of head injury, injury occurred more than 12 hours ago, patient admitted to hospital more than 4 hours after injury, primary bleeding source located to the extremeties, treated with aprotinin, known history of a thromboembolic event, presence of spinal cord injury, burns greater than 40% TBSA, known or suspected pregnancy, estimated body weight less than 43 kg, suspected allergy to trial product or known presence of congenital bleeding disorder.
Treatment	1.  Three single doses of (rFVIIa/NovoSeven®/NiaStase®) or placebo (inactive drug) given IV over a three hour period. 2.  Patient will be monitored for the first thirty days following drug administration for initial injury, vital signs, ventilator status, hospital stay and treatments, medications, IV fluids, transfusions, surgeries, bleeding status, medications and adverse events. 3.  Blood samples will be obtained at baseline, Hour 6, Hour 12, Hour 24, Hour 48 and daily through Day 30 4.  ABG's at baseline and daily while patient is on ventilator through Day 30. 5.  FVII 5-10 minutes after the first dose and between 65 minutes and 12 hours after the first dose at a specified time point assigned to each site. 6.  D-dimer only upon diagnosis of suspected DIC
Principal Investigator	Fred A. Luchette, MD
Enrollment Phone	708 327-2457
Title	An open label randomized, multicenter study to evaluate the efficacy and safety of early calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on mycophenolate mofetil; MMF (CellCept®) and sirolimus (Rapamune®).  (Spare the Nephron)
Purpose	1.  The purpose of this study is to see if calcineurin inhibitor withdrawl will increase graft survival in kidney transplant patients. 2.  The aim of this study is to test treatment combinations that preserve the new kidney and minimize the risk of adverse side effects
Study Number	108371
Number of Patients	340
Eligibility	A person may be enrolled into the study if they are between 18 –75 years of age and received a primary renal transplant between 30 – 180 days ago, they have been maintained on a regimen of cyclosporine or tacrolimus, CellCept with or without corcicosteroids for at least 14 days before randomization, sign a study consent and if female have a negative pregnancy test.   Patients will be excluded from the study if they are experiencing a steroid-resistant biopsy-proven rejection episode or treated for acute rejection with monoclonal or polyclonal antibody therapy within 90 days prior to randomization, experiencing a corticosteroid sensitive acute rejection episode within 30 days prior to randomization, have more than one biopsy proven acute rejection episode prior to study entry, previously received or are receiving an organ transplant other than a kidney, have a serum creatinine of greater than 2.5 mg/dl and/or creatine clearance of  less than 30 ml/min, are allergic to cold iothalamate or iodine, have received sirolimus prior to study entry, have severe diarrhea or other gastrointestinal disorders, have evidence of an active systemic infection requiring the use of antibiotics, have HIV, chronic active hepatitis B or C, have a history of malignancy in the last 5 years, have severe anemia (Hgb less than 8 g/dl) , leukopenia (WBC less than 4000/mm) or thrombocytopenia (platelet count less than 100,000/mm), have total cholesterol levels greater than 300 mg/dl or triglycerides greater than 350 mg/dl, require dialysis at the time of study entry, or receiving experimental immunosuppressive agents.
Treatment	1.  Some treatment groups will receive CellCept and Rapamune for the whole trial. 2.  Some treatment groups will receive CellCept and cyclosporine for the whole trial. 3.  Some treatment groups will receive CellCept and Prograf for the whole trial. 4.  Blood draws for laboratory tests and/or to determinie dose of medications will be performed at each visits.  There will be a total of 9 study visits including the screening visit. 5.  At screening some patients may require "MPA Monitoring". These patients will have a series of 3 blood draws over two hours. One sample will be obtained at time zero - just prior to receiving morning dose of mycophenolate mofetil. The second sample will be obtained 30 minutes after the morning dose. And the third blood sample will be obtained two hours after the morning dose. These samples will be sent to a central lab. 6.  Measurement of glomerular filtration rate (GFR) determined by the renal clearance of cold iothalamate injected subcutaneously will be done at visit one, visit seven (one year follow-up) and visit eight (two year follow-up). This will also involve obtaining two blood samples and two urine samples collected over two hours. These samples will be sent to a central lab. 7.  24 hour urine collection will be done at visit one (screening), visit seven (one year follow-up) and visit eight (two year follow-up).
Principal Investigator	David Robb Holt, MD
Enrollment Phone	708 327-2457