The purpose of this study is Comparison of desmopressin with placebo, in Hemostasisafter heart transplant surgery. Therefore, Heart transplant candidates with no previous history of thoracic surgery, chronic respiratory disease and hereditary or acquired coagulation disorders Will be studied. 40 patients referring to Masih Hospital and Heart Center Shahid Rajaee divided into 2 groups. In one group 2 mL of saline injection and another group that 0.3 micrograms per killogeram desmopressin with volume of 2 ml injection then have to determine the hemostatic medicine, blood volume Chest tube, blood volume and FFP for the first 24 hours and need a second surgery in the first 48 hours after surgery are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010512642N8
Registration date:2015-01-25, 1393/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of desmopressin with placebo, in Hemostasis after heart transplant surgery
Public title
The effect of desmopressin in reducing the incidence of heart transplant surgery complication
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age between 20-70 years old; Heart transplant surgery
exclusion criteria: History of previous surgery on chest; Bleeding disorders and hemophilia; Patients with preoperative coagulation tests and platelet be disrupted; Contraindications for use of DDAVP; History of deep vein thrombosis-hematologic disease- carotid plaque due to sever narrowing; Chronic obstructive pulmonary disease
Age
From 20 years old to 70 years old
Gender
Both
Phase
1-2
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology Ethics Committee Shahid Beheshti University of Medical S
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
Sbmu1.REC.1393.78
Health conditions studied
1
Description of health condition studied
transplant cardiac surjery
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ
Primary outcomes
1
Description
Chest tube blood volume
Timepoint
During the first 24 hours after surgery
Method of measurement
cc with a calibrated container
2
Description
Blood volume required for transfusion
Timepoint
During the first 24 hours after surgery
Method of measurement
Based on the number of units transfused
3
Description
FFP volume required for transfusion
Timepoint
During the first 24 hours after surgery
Method of measurement
Based on the number of units injected
Secondary outcomes
1
Description
thrombin time
Timepoint
before and after transplant surjery
Method of measurement
According to the second with lab kit
2
Description
platelet count
Timepoint
Before and after transplantat surjery
Method of measurement
Based on the number of platelets per ml of blood
Intervention groups
1
Description
Prescribed 0.3ug / kg desmopressin with 2 ml volume before transplant surgery
Category
Prevention
2
Description
2 mL of saline administered before transplantation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Darabad Ave
City
Tehran
2
Recruitment center
Name of recruitment center
Tehran Heart Surgery Center
Full name of responsible person
Majid Golestani Eraghi
Street address
Valiasr Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technological Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Ave, Velenjak
City
Tehran
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 and Technological Shahid Beheshti University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Jahangirifard
Position
Cardiac Anesthesia Fellowship
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship subspecialty care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
00
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)