Reduced postoperative bleeding in open heart surgery patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 194 patients.
Settings and conduct
All patients undergoing open heart surgery will be included in the study, according to a specialist in cardiovascular surgery.
An expert who will be responsible for measuring bleeding will be blinded in terms of knowledge of the type of medication.
Desmopressin and Sodium Chloride 0.9 sprays are given by the anesthesiologist in the operating room 30 minutes before the operation at a rate of 0.3 micrograms per kilogram, respectively, to each patient in the intervention and control group.
The person giving the medicine in the operating room and the person who measures the patient's bleeding in the ICU OH section are the same for both groups and do not know what group the patient is in and what medication he has received
Participants/Inclusion and exclusion criteria
All patients are candidates for open heart surgery subject to informed consent
Conscious dissatisfaction
Intervention groups
The intervention group will receive 0.3 micrograms per kilogram of desmopressin half an hour before the start of surgery.
The control group will receive 0.3 micrograms per kilogram of 0.9 sodium chloride half an hour before the start of surgery.
Main outcome variables
Postoperative bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200424047185N1
Registration date:2020-05-26, 1399/03/06
Registration timing:registered_while_recruiting
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Hamed Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 4340
Email address
kianihamed93@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Desmopressin on The Post Operative Bleeding in Patients Undergoing Open Heart Surgery
Public title
The Effect of Desmopressin on The Post Operative Bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for open heart surgery
Exclusion criteria:
Blood coagulation disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
Easy (available) sampling, in which two groups of age and sex will be matched and matched frequently using stratified randomization. The explanation of this method is that after entering the study, patients are divided into two groups, male and female, which in each group of patients are divided into two categories of patients under 50 years of age and over 50 years of age. Depending on the accident, individuals will be assigned to two intervention groups and a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
An expert who will be responsible for measuring bleeding reduction will be blinded in terms of knowledge of the type of medication. Desmopressin and normal saline sprays are given to each of the patients in the intervention or control group 30 minutes before the operation, respectively, by the anesthesiologist in the operating room 30 minutes before the start of the operation. The pharmacist and the person measuring the patient's bleeding at ICUOH are the same for both groups and do not know what group the patient is in and what medication he or she has received (they are blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.ZAUMS.REC.1399.027
Health conditions studied
1
Description of health condition studied
Bleeding - open heart surgery - Desmopressin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative bleeding
Timepoint
Measure the patient's bleeding rate two, six, eight, twelve, and twenty-four hours after surgery
Method of measurement
The amount of blood in the Chest Bottle is in milliliters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Desmopressin is an artificial analogue of vasopressin group. 0.3 micrograms per kilogram is given to each patient of the intervention group 30 minutes before the operation.
Category
Treatment - Surgery
2
Description
Control group: Sodium chloride solution is 0.9% injectable, a sterile, non-febrile solution, free of preservatives and isotonic, and contains 9 mg of sodium chloride per ml. 0.3 micrograms per kilogram is given to each patient in the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital
Full name of responsible person
Azadi Ahmad Abadi Changiz
Street address
Salamat Blvd - Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
public@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
AzadiAhmad Abadi Changiz
Street address
Campus of Medical Sciences - Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Azadiahmadabadi Changiz
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Heart surgery
Street address
Salamat Blvd-Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
kianihamed93@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Azadiahmadabadi Changiz
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Heart surgery
Street address
Salamat Blvd-Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
kianihamed93@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Azadiahmadabadi Changiz
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Heart surgery
Street address
Salamat Blvd-Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
0098 54 3329557
Email
kianihamed93@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available