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NCT00631787 · ClinicalTrials.gov registry record
Evaluation of Toxicity From Stem Cell Transplant
A clinical trial of Hemolysis and Organ Dysfunction, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 61
- Enrollment target
- 1
- Study location
NCT00631787: Completed study of Hemolysis and Organ Dysfunction, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00631787 is a study of Hemolysis and Organ Dysfunction that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 61 participants, below the 390-participant average among 3 other Hemolysis trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00631787, a study of Hemolysis and Organ Dysfunction, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will try to determine what causes toxic side effects of stem cell transplantation, such as increased blood pressure, increased heart rate, decreased kidney function and abnormal heart rhythms. Stem cells are used to treat various diseases, including cancer, aplastic anemia and sickle cell disease. The cells may be given fresh to the patient or they may be preserved first with a chemical called DMSO and frozen for later use. Some stem cell transplant procedures include infusion of red blood cells along with the stem cells. This study will examine whether side effects of stem cell transplants are associated with the DMSO preservative in frozen cells or with hemoglobin (a protein released from defrosted red blood cells) or neither of these factors. Healthy volunteers and patients scheduled to receive a stem cell transplant may be eligible for this study. Candidates must be between 10 and 80 years of age. Transplant patients will undergo a stem cell transplant. The cells are infused through a catheter placed in a vein for the procedure. Depending on the patient s requirements, the infusion may or may not include red blood cells and may or may not contain DMSO. Healthy volunteers undergo a 4-hour saline infusion. The saline (water mixed with salt) is infused through a catheter (plastic tube) placed in a vein in the arm. In addition, all participants have the following tests and procedures: * Heart monitoring: Healthy volunteers wear a portable heart monitor, attached to the chest using four stickers, for 24 hours starting the morning of the infusion. Transplant patients wear the same device for 48 hours, starting the morning before the infusion. * Blood draws and urine collections before, during, just after and the morning after the infusion of saline or stem cells. * Heart ultrasound before, during or just after and the morning after the infusion. * Peripheral artery tonometry: A small cup is placed on one finger of each hand to measure blood flow in the f
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2008-02-29 |
| Est. Completion | 2015-12-07 |
What the finished NCT00631787 record still lists
NCT00631787 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 390-participant average among 3 other Hemolysis trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Hemolysis appearing as the primary indexed condition, and to 0 interventions.
NCT00631787 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00631787 about?
NCT00631787 is a clinical study titled "Evaluation of Toxicity From Stem Cell Transplant". This study will try to determine what causes toxic side effects of stem cell transplantation, such as increased blood pressure, increased heart rate, decreased kidney function and abnormal heart rhythms. Stem cells are used to treat various diseases, including cancer, aplastic anemia and sickle cell...
What is the current status of trial NCT00631787?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2008-02-29. Estimated completion is 2015-12-07.
What conditions does trial NCT00631787 study?
This clinical trial studies the following conditions: Hemolysis, Organ Dysfunction.
Who is sponsoring clinical trial NCT00631787?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00631787 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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