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The effect of desmopressin in reducing bleeding after cardiac surgery in patients receiving antiplatelet drugs in comparison with placebo

Protocol summary

Summary
The purpose of this study is the evaluation of effect of desmopressin in reducing bleeding after cardiac surgery in patients receiving antiplatelet drugs. After approval of the proposal and obtaining the approval of the ethics committee, patients older than 18 years (40 patients in two groups) who underwent CABG and did not interrupt their anti platelets agents (clopidegrol or aspirin) a week before surgery will be enrolled in this study. Patients who have a history of coagulation disorders will be excluded. All patients will pre-medicate before surgery. After induction of anesthesia bleeding time (BT) will be measured. CABG surgery will be performed under CPB. After reverses of heparin by protamine, patients will be divided into two groups. Group 1 (cases)(20 patients) DDAVP nasal spray two puffs and in group 2 (control)(20 patients) normal saline nasal spray two puffs into the patient's nose will use and patients will be transferred to the ICU . In ICU blood samples for assessment of PT, PTT, INR, Platelet, ACT will be sent after an hour of admission. BT will be measured again. Six hours later re- sprays will be prescribed. Patient's vital signs , amount of hemorrhage, administration of blood products , prescription drugs for improving coagulation, required re-operation to control bleeding, the sternum was left open, patient mortality, length of ICU stay, duration of mechanical ventilation will be recorded .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092114728N1
Registration date: 2014-03-19, 1392/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Kamran Shadvar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1994
Email address
shadvark@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of desmopressin in reducing bleeding after cardiac surgery in patients receiving antiplatelet drugs in comparison with placebo
Public title
The effect of desmopressin in reducing bleeding after cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: CABG surgery under CPB, Age over 18 years, Anti-platelet drugs for one week before surgery Exclusion Criteria: Heart surgery (other than surgery to control bleeding), coagulation disorders, anticoagulation before surgery, patient dissatisfaction, sensitivity to DDAVP, kidney disease, liver disease
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
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
Tabriz University of Medical Sciences
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Approval date
2014-01-25, 1392/11/05
Ethics committee reference number
92175

Health conditions studied

1

Description of health condition studied
Bleeding after cardiac surgery
ICD-10 code
D68/8
ICD-10 code description
Other specified coagulation defects

Primary outcomes

1

Description
Amount of Bleeding
Timepoint
Every 6 hours
Method of measurement
ML

Secondary outcomes

1

Description
Duration of ICU stay
Timepoint
After Intervention
Method of measurement
Hour

Intervention groups

1

Description
Administration of DDAVP nasal spray 2 puffs before admission to ICU and 6 hours later
Category
Treatment - Drugs

2

Description
Administration of saline nasal spray 2 puffs before admission to ICU and 6 hours later in control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Madani Heart Center
Full name of responsible person
Dr Kamran Shadvar
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Magami
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Scieces
Full name of responsible person
Dr Kamran Shadvar
Position
ICU fellowship
Other areas of specialty/work
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 1335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Kamran Shadvar
Position
ICU fellowship
Other areas of specialty/work
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 1335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Kamran Shadvar
Position
ICU fellowship
Other areas of specialty/work
Street address
Central building of Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 1335 7767
Fax
Email
shadvark@tbzmed.ac.ir
Web page address

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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