The purpose of this double blind randomized clinical trial is assessment of Vasopressin effect on reduction of bleeding in patients under Total Hip Arthroplasty surgery. In this study, 80 patients who are eligible will be allocated in one of the intervention or control groups. Patients in the intervention group will receive Vasopressin 1% unit/minute during operation and in the control group will receive placebo in the similar appearance and dosage. The number of blood packages (transfusion) during operation, Hemoglobin, platelet, Prothrombin time (Pt), Partial thromboplastin time (Ptt), International Normalized Ratio (INR) will be measure and compared before and after operation in groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108173773N4
Registration date:2011-09-02, 1390/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-02, 1390/06/11
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Medical school
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Vasopressin effect on reduction of bleeding in patients under Total Hip Arthroplasty surgery
Public title
Assessment of Vasopressin effect on reduction of bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: A.S.A class 1&2, Age: 20-80, undergoing Total Hip Arthroplasty under Regional Anesthesia
Exclusion criteria: Bleeding disorders, Previous Total Hip Arthroplasty
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
Ghods cross, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2011-07-28, 1390/05/06
Ethics committee reference number
663/130/د/90
Health conditions studied
1
Description of health condition studied
Vasopressin
ICD-10 code
Y42.9
ICD-10 code description
Other and unspecified hormone antagonists
Primary outcomes
1
Description
transfusion
Timepoint
during operation
Method of measurement
Nomber of Blood package
Secondary outcomes
1
Description
Hemoglobin
Timepoint
After operation
Method of measurement
Labratory instrument (scale g/dL)
2
Description
platelet
Timepoint
After operation
Method of measurement
Labratory instrument
3
Description
Prothrombin time = Pt
Timepoint
After operation
Method of measurement
Labratory instrument
4
Description
Partial thromboplastin time = Ptt
Timepoint
After operation
Method of measurement
Labratory instrument
5
Description
International Normalized Ratio = INR
Timepoint
After operation
Method of measurement
Labratory instrument
Intervention groups
1
Description
Intervention group patients receive Vasopressin 1% unit/minute during operation.
Category
Treatment - Drugs
2
Description
Control group patients receive placebo during operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant professor
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant Professor
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Anesthesia Group, Tehran University of Medical Sciences
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant Professor
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
Email
imanifar@tums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesia Group, Tehran University of Medical Sciences
Full name of responsible person
Farsad Imani M.D.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 66348500
Fax
Email
imanifar@tums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farsad Imani M.D.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 66348500
Fax
Email
imanifar@tums.ac.ir
Web page address
www.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)