Protocol summary

Summary
Design: A randomized clinical trial, phase 3 study of the population of 29 individuals, including 14 in the control group and 15 patients without blinding How to study and interventions and participants: All patients regularly undergo periodic tests, renal, hematologic and biochemical and standard treatment, normal, and defined these diseases include supportive therapy and blood product administration, as required by If symptoms are severe or clinical laboratory and blood coagulation (DIC) immediately admitted in ICU hospital patients in the study group after the initial application by the blood, are treated with plasmapheresis. (in plasmapheresisa pilot study carried out for each patient is considered average 3 times). The main outcome: platelet count; ceratinin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110524884N1
Registration date: 2016-06-29, 1395/04/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Mitra Moghaddaspour
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9937
Email address
moghaddaspour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Plasmaphresis in Disseminated Intravascular Coagulation after a sting of Hemiscorpius lepturus
Public title
Evaluation of efficacy of Plasmaphresis in Disseminated Intravascular Coagulation after a sting of Hemiscorpius lepturus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Laboratory and clinical signs of disseminated intravascular coagulation (DIC) for scorpion stung Exclusion criteria: death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo AV. Velenjak
City
Tehran
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
IR.SBMU.SM.REC.1394.58

Health conditions studied

1

Description of health condition studied
disseminated intravascular coagulation
ICD-10 code
D65
ICD-10 code description
Disseminated intravascular coagulation [defibrination syndrome]

Primary outcomes

1

Description
platelet; ceratinin
Timepoint
after plasmapheresis
Method of measurement
laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: plasmaphresis on average 2 times plus conservative terapy
Category
Treatment - Other

2

Description
control group: conservative terapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Ahmad Ghorbani
Street address
Felestin st
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Babak Mostafazade
Street address
Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Shahid Beheshtil Univercity of Medical Science
Full name of responsible person
Dr. Mitra moghaddaspour
Position
Forensic Medicine Resident
Other areas of specialty/work
Street address
Tehran-Velenjak
City
Tehran
Postal code
ایران
Phone
00
Fax
Email
mitra.moqaddaspour@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr. Babak Mostafazade
Position
Associate professor,Forensic Medicine
Other areas of specialty/work
Street address
Tehran-Velenjak
City
Tehran
Postal code
Phone
+98 21 5541 9000
Fax
Email
mstzbmd@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...