Status:
COMPLETED
Evaluation of Toxicity From Stem Cell Transplant
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Organ Dysfunction
Hemolysis
Eligibility:
All Genders
10-80 years
Brief 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 rhyth...
Detailed Description
Allogeneic and autologous bone marrow transplantation is currently the only curative option for many patients with life-threatening hematologic illnesses and malignancies. Peripheral blood stem cell (...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA HEALTHY VOLUNTEERS:
- Ages 10 to 80
- Normal renal function: creatinine less than 1.5 mg/dL in subjects greater than or equal to 18 years of age, less than or equal to 1.0 mg/dL in subjects 13 to 17 years of age, less than or equal to 0.7 in subjects 10 to 12 years of age, and proteinuria less than 1+
- Normal liver function: bilirubin less than 1.5 mg/dL and transaminases within normal limits
- Normal pulmonary arterial pressure by transthoracic echocardiogram (tricuspid regurgitant velocity less than 2.5 m/s)
- Ability to comprehend and willing to sign an informed consent/assent
- INCLUSION CRITERIA ALL OTHERS:
- Ages 10-80
- Otherwise as stated on the subject s primary protocol
- EXCLUSION CRITERIA HEALTHY VOLUNTEERS:
- History of clinically significant cardiac or pulmonary disease
- EXCLUSION CRITERIA ALL OTHERS:
- Patients receiving nitrate antihypertensive medications
- Clinically unstable patients in which transfer to the intensive care unit is being considered
- Otherwise as stated on the subject s primary protocol
Exclusion
Key Trial Info
Start Date :
February 29 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 7 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00631787
Start Date
February 29 2008
End Date
December 7 2015
Last Update
June 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892