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Effect of Desmopressin on bleeding in coronary artery bypass graft surgery patients undergoing cardiopulmonary bypass pump with antiplatelet drugs

Protocol summary

Summary
The purpose of this study was to evaluat the effect of Desmopressin on bleeding in coronary artery bypass graft (CABG) surgery patients undergoing cardiopulmonary bypass pump who have received antiplatelet drugs 100 patients who are candidate for CABG enter to the study and divide into two groups.ّFor all patients, hemoglobin, platelet count, PT, INR, PTT, BTand CT will be measured. A dose of Desmopressin is given as two drops to the first group before surgery. For the second group the same amount of normal saline is given as placebo. All patients routinely underwent coronary artery bypass graft surgery under general. After surgery, patients were transferred to ICU. Second dose of Desmopressin as two drops 6 hours after the first dose is given to the first group and the same amount of normal saline is given to second group as placebo. One hour after second dose Hemoglobin, platelet count, PT, INR, PTT and BT are checked again. Side effects include nausea and vomiting, hypotension, postoperative blood loss, need for blood transfusions and platelet transfusions during the first 24 hours were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409304345N3
Registration date: 2014-12-02, 1393/09/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-02, 1393/09/11
Registrant information
Name
Ali Mirmansouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
a_mirmansoori@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-03-10, 1393/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Desmopressin on bleeding in coronary artery bypass graft surgery patients undergoing cardiopulmonary bypass pump with antiplatelet drugs
Public title
Effect of Desmopressin on bleeding after coronary artery bypass graft
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for CABG; antiplatelet drugs Exclusion criteria: Need to get an postoperative anticoagulation
Age
From 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2014-08-26, 1393/06/04
Ethics committee reference number
1930252810

Health conditions studied

1

Description of health condition studied
Complications of Coronary artery bypass grafting
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts

Primary outcomes

1

Description
Blood transfusion
Timepoint
During 24 hours after surgery
Method of measurement
Hemoglobin less than 9 by Sysmex K1000

2

Description
Platelet transfusions
Timepoint
During the first 24 hours after surgery
Method of measurement
Based on the platelet less than 100000

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Giving 10-40 microgram desmopressin as two drops before CABG and repeat it 6 hours later, after surgery, in ICU
Category
Treatment - Drugs

2

Description
Intervention 2: Giving 10-40 microgram normal saline as two drops before CABG and repeat it 6 hours later, after surgery, in ICU
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Heshmat Hospital
Full name of responsible person
Ali Mirmansouri
Street address
Heshmat Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
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 of Guilan 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
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Mirmansouri
Position
Anesthesiologist; Associate Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmai.com
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Mirmansouri
Position
Anesthesiologist; Assosiate proffessor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician; Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir

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
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