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Acute Normovolomic Hemodilution effect on the amount of bleeding after Coronary Artery Bypass Grafting surgery in the first 48 hours postoperative

Protocol summary

Summary
(1) Objectives: The main aim of this study is to consider acute normovolemic hemodilution effect on the amount of bleeding after coronary artery bypass grafting surgery in the first 48 hours after surgery. (2 and 3) Design, Setting and conduct: The study is a single-blind, single-centre, interventional clinical trial in which, 100 patients who are candidate for coronary artery bypass graft (CABG) surgery at Imam Khomeini hospital of Ardabil will be randomly allocated into two equal groups of intervention and control. (4) Participants including major eligibility criteria: no previous known history of coagulation disorders, and, no previous treatment with drugs used in coagulation disorders. The exclusion criteria are as follows: anemia (hemoglobin less than 11), massive transfusion (more than 1 blood volume or 20 packed cell), platelet transfusion, FFP transfusion, receiving medications such as Plavix and Transamine, connection to the CPB pump more than 3 hours, and platelet count less than 100 thousand. (5) Intervention: After induction of anesthesia in the operating room and before connecting the patient to the CPB pump, a blood unit is taken from patients in the intervention group. After completion of the surgical procedure and disconnecting of patients from the CPB pump and receiving protamine, the whole blood of patients in intervention group is retransfused. For patients in the control group, the surgery process will be performed without these measures. (6) main outcome measures (variables): Patients in the two groups will be compared in terms of bleeding within 48 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041933529N1
Registration date: 2017-08-07, 1396/05/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Sahar Khakavi
Name of organization / entity
Ardabil University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 0404
Email address
s.khajoo@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Ardabil medical university, Ardabil
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acute Normovolomic Hemodilution effect on the amount of bleeding after Coronary Artery Bypass Grafting surgery in the first 48 hours postoperative
Public title
Acute Normovolomic Hemodilution effect on the amount of bleeding after Coronary Artery Bypass Grafting surgery in the first 48 hours postoperative
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No previous known history of coagulation disorders; No previous treatment with drugs used in coagulation disorders. Exclusion criteria: Anemia (hemoglobin less than 11); Massive transfusion (more than 1 blood volume or 20 packed cell); Platelet transfusion; FFP transfusion; Receiving medications such as Plavix and Transamine; Connection to the CPB pump more than 3 houres; platelet count less than 100 thousand.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee Of Ardabil University Of Medical Sciences
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5615751147
Approval date
2016-06-27, 1395/04/07
Ethics committee reference number
IR.ARUMS.REC.1395.47

Health conditions studied

1

Description of health condition studied
coronary artery bypass graft
ICD-10 code
I25.70
ICD-10 code description
unspecified coronary artery bypass graft

Primary outcomes

1

Description
amount of bleeding
Timepoint
36 measurements in 2-hour intervals (12 times per day, in the first 3 days)
Method of measurement
by graduated drains (in terms of mL)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After induction of anesthesia in the operating room and before connecting the patient to the CPB pump, a blood unit is taken from patients in the intervention group. After completion of the surgical procedure and disconnecting of patients from the CPB pump and receiving protamine, the whole blood of patients in intervention group is retransfused.
Category
Treatment - Other

2

Description
Control group: No intervention will be given in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital of Ardabil city
Full name of responsible person
Sahar Khajavi
Street address
Imam Khomeini hospital , Ataee St, Ardabil
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Hadi Piri dogahe
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
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, Ardabil 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
Ardabil University Of Medical Sciences
Full name of responsible person
Sahar Khajavi
Position
medical student
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5619853141
Phone
+98 455512006
Fax
Email
S.khajoo@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Akbar Pirzadeh
Position
Associate Professor / ENT specialist
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5615751147
Phone
+98 45 3352 2083
Fax
Email
a.pirzadeh@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Sahar Khajavi
Position
medical student
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5615751147
Phone
+98 455512006
Fax
Email
S.khajoo@arums.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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