Comparison between efficacy of multiple courses of high-dose dexamethasone therapy and single course of high dose dexamethasone in the treatment of newly diagnosed primary immune thrombocytopenia
Objective: Comparison the efficacy of multiple courses of high-dose dexamethasone with single course of high dose dexamethasone in the treatment of newly diagnosed primary immune thrombocytopenia
Design: An interventional double blind randomized clinical trial was designed in Ali-Ebne Abitalib (A) Hospital in Zahedan.
Setting and conduct: All Primary and newly diagnosed immune thrombocytopenia patients in hematology oncology ward in Ali-Ebne Abitalib (A) were evaluated.
Participants: All Primary and newly diagnosed immune thrombocytopenia patients in Ali-Ebne Abitalib (A) Hospital in Zahedan enrolled the study. Inclusion criteria: Platelet count less than 20000; platelet count more than 20000 in cases with bleeding.
Exclusion criteria: comorbidities such as Diabetes, Liver disease, HIV; Previous History of immune thrombocytopenic purpura; recently use of corticosteroids; history of systemic lupus erythmatous;
No consent (declining) for participating in study.
Intervention: In this clinical trial sampling was by convenient method. Overall 40 patients with newly diagnosed immune thrombocytopenic purpura who were admitted to the hematology & oncology ward in Ali-Ebne Abitalib Hospital, were randomly allocated to the two groups, one group receiving single course of dexamethasone plus prednisolone (odd numbers) and another group (pair numbers) receiving 4-6 courses of dexamethasone every 14 days. Data collector did not know anything about allocation of cases, the analysor did not know as well.
Main outcome measurements: Platelet count was the main outcome measure in different time intervals and corticosteroid complications were evaluated and were collected. Data were analyzed by SPSS ver 19 using Chi-square and Cochran.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110424881N1
Registration date:2016-07-02, 1395/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Zahra Sepehri
Name of organization / entity
Zabol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 0768
Email address
sepehri_za@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental (Grant from deputy of research in Zahedan University of Medical Sciences),
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy of multiple courses of high-dose dexamethasone therapy and single course of high dose dexamethasone in the treatment of newly diagnosed primary immune thrombocytopenia
Public title
Efficacy of frequent high dose dexamethasone in treatment of primary immune thrombocytopenic purpura
Purpose
Treatment
Inclusion/Exclusion criteria
All Primary and newly diagnosed immune thrombocytopenic purpura patients enrolled the study.
Inclusion criteria: Platelet count less than 20000; platelet count more than 20000 in cases with bleeding.
Exclusion criteria: comorbidities such as diabetes; liver or renal disease; HIV; Previous history of immune thrombocytopenic purpura; recently use of steroids; history of systemic lupus erythmatous;
No consent (declining) for participating in study
Age
From 15 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan university of medical sciences
Street address
Hesabi square
City
Zahedan
Postal code
9816743463
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
Zums.1.REC.1392.956
Health conditions studied
1
Description of health condition studied
Newly diagnosed immune thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Immune thrombocytopenic purpura
Primary outcomes
1
Description
Platelet count
Timepoint
Monthly till 12 months after treatment course
Method of measurement
Cell Blood Count; Platelet count
Secondary outcomes
1
Description
Blood pressure
Timepoint
Monthly after treatment and every 15 min during dexamethasone courses
Method of measurement
By manometer
Intervention groups
1
Description
Intervention: The group of patients who received 4-6 courses of high dose dexamethasone every 14 days
Category
Treatment - Drugs
2
Description
Control: The group of patients who received single course of dexamethasone plus oral prednisolone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebne Abitalib Hospital
Full name of responsible person
Zahra sepehri
Street address
Rajaee street,
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Science
Full name of responsible person
Dr Houshang Rafighdoost
Street address
Number 10, Hesabi square, Pardis of the University
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zahra Sepehri
Position
Vice Chancellor for Research, Assistant Professor
Other areas of specialty/work
Street address
Number 123, Rajaee street
City
Zabol
Postal code
9861611558
Phone
+98 54 3223 0768
Fax
+98 54 3223 0770
Email
Sepehri_za@zbmu.ac.ir
Web page address
Www.zbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
MohammadAli Mashhadi
Position
Full Professor
Other areas of specialty/work
Street address
Number101, Hesabi square
City
Zahedan
Postal code
9813636543
Phone
+98 54 3223 1375
Fax
Email
Mamashhadi67@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zahra Sepehri
Position
Vice Chancellor for Research
Other areas of specialty/work
Street address
Number 123, Rajaee street
City
Zabol
Postal code
9861611558
Phone
+98 54 3223 0768
Fax
Email
Sepehri_za@zbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)