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Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00872833
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : August 27, 2014
Last Update Posted : October 7, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthCore-NERI

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Thalassemia
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Younger Cohort Older Cohort
Hide Arm/Group Description People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study. People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
Period Title: Overall Study
Started 15 17
Completed 15 17
Not Completed 0 0
Arm/Group Title Overall
Hide Arm/Group Description Both cohorts combined
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
31.8  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
18
  56.3%
Male
14
  43.8%
1.Primary Outcome
Title Report of Pain by Age Group
Hide Description Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
Time Frame measured daily over the 3 transfusion cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Younger Cohort Older Cohort
Hide Arm/Group Description:
People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
Overall Number of Participants Analyzed 15 17
Overall Number of Units Analyzed
Type of Units Analyzed: Participant-cycles
40 43
Measure Type: Number
Unit of Measure: percentage of participant-cycles
Start of cycle 23 61
25% through cycle 18 51
50% through cycle 15 47
75% through cycle 20 54
End of cycle 18 56
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Younger Cohort, Older Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Report of Pain by Length of the Transfusion Cycle
Hide Description Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.
Time Frame measured daily over the 3 transfusion cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.
Arm/Group Title <= 14 Days 15 - 21 Days 22 - 28 Days > 28 Days
Hide Arm/Group Description:
Subjects with transfusion cycles of 14 days or less
Subjects with transfusion cycles between 15 and 21 days
Subjects with transfusion cycles between 22 and 28 days
Subjects with transfusion cycles greater than 28 days
Overall Number of Participants Analyzed 5 12 17 13
Overall Number of Units Analyzed
Type of Units Analyzed: Participant-cycles
10 25 26 22
Measure Type: Number
Unit of Measure: percentage of participant-cycles
Start of cycle 50 40 42 41
25% through cycle 50 48 35 14
50% through cycle 50 48 23 14
75% through cycle 60 52 31 18
End of cycle 50 44 31 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <= 14 Days, 15 - 21 Days, 22 - 28 Days, > 28 Days
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data were not collected for this observational study
 
Arm/Group Title Adverse Events Were Not Collected
Hide Arm/Group Description Adverse events were not collected as part of this observational study.
All-Cause Mortality
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events Were Not Collected
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Gerstenberger
Organization: New England Research Institutes, Inc.
Phone: 6179237747
EMail: egerstenberger@neriscience.com
Layout table for additonal information
Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT00872833    
Other Study ID Numbers: 640
U01HL065238 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2009
First Posted: March 31, 2009
Results First Submitted: April 9, 2014
Results First Posted: August 27, 2014
Last Update Posted: October 7, 2015