The main objective of this study is to determine the effect of postoperative active warming of patient on bleeding and coagulation factor after off-pump coronary artery bypass graft surgery. This randomized clinical trial will be performed on 60 patients undergoing off-pump coronary artery bypass graft surgery. Inclusion criteria consist of: Patients are candidate for OPCAB, between 30-70 years old, no history of previous CABG, Normal coagulation tests include: pt, ptt and platelet count before surgery, ventricular ejection fraction more than 35% of output, The absence of preoperative coagulation disorders, written informed consent to participate in the study. exclusion criteria consist of: need for high dose inotrope after CABG, Need for IABP in perioperation, Need for cardiopulmonary bypass intra operation. in intervention group: Active warming of patient will be started after admission in ICU (to reach 36.7°C). in control group will be used a bedsheet. Chest tube drainage will be recorded 6 and 24 hours after the operation. Packed red blood cell requirement will be recorded 24 hours after the operation. coagulation profiles will be recorded immediately after and 6 hours after the operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111315395N1
Registration date:2014-06-14, 1393/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
razie zare bezg abadi
Name of organization / entity
shahid sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 52 35971
Email address
zare.razie@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd shahid sadoughi university of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of postoperative active warming of patient on bleeding and coagulation factor function after off-pump coronary artery bypass graft surgery
Public title
Effect of warming of patient on bleeding and coagulation factor after coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients are candidate for OPCAB between 30-70 years old; no history of previous CABG; Normal protrombin time partial tromboplastin time and platelet count before surgery; ventricular ejection fraction more than 35% of output; written informed consent to participate in the study.
exclusion criteria: need for high dose inotrope after CABG; Need for IABP in perioperation; Need for cardiopulmonary bypass intraoperation.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Bahonar Square, Headquarters Yazd University
City
Yazd
Postal code
8916877443
Approval date
2013-10-21, 1392/07/29
Ethics committee reference number
17/1/141446/پ
Health conditions studied
1
Description of health condition studied
Coronary artery Bypass Graft Patients
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Level of prothrombin time, activated partial thromboplastin time, and platelet count
Timepoint
At time zero and 6 hours after surgery
Method of measurement
prothrombin time and activated partial thromboplastin time measured by second and platelet count by number in cubic milimeter
2
Description
The rate of postoperative bleeding
Timepoint
At 6 and 24 hours after surgery
Method of measurement
Measure Chest bottle drainage by cc
Secondary outcomes
1
Description
Packed red blood cells transfused
Timepoint
24 hours after surgery
Method of measurement
number of units of packed red blood cells transfused within 24 hours after operation
Intervention groups
1
Description
in control group will be used a bedsheet
Category
Prevention
2
Description
in intervention group: Active warming of patient will be started after admission in ICU (to reach 36.7°C).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Afshar Hospital
Full name of responsible person
Mrs. H.Dehghani
Street address
Yazd University of Medical Sciences, School of Nursing
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.f.Ezoddini
Street address
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
City
Yazd
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, Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences, Yazd, School of Nursing
Full name of responsible person
Razie Zare Bezg abadi
Position
Student nurse in master of critical care nursing
Other areas of specialty/work
Street address
Afshar hospital, Jomhuory Boulevard, Yazd, Iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1523 5971
Fax
Email
zare.razie1@gmail.com zare.razie@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Iran
Full name of responsible person
Mrs. H.Dehghani
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
School of Nursing, St Bou Ali, Brigadier Fallahi Boulevard, yazd, iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1824 1754
Fax
Email
hamide.dehghani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences, School of Nursing
Full name of responsible person
Razie Zare Bezg abadi
Position
Master Nurse Student of critical care nursing
Other areas of specialty/work
Street address
Afshar hospital, Jomhuory Boulvar, Yazd, Iran
City
Yazd
Postal code
8916877443
Phone
+98 35 1523 5971
Fax
Email
zare.razie1@gmail.com zare.razie@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)