The efficiency and effectiveness of the ACT, ROTEM protocol for neutralizingprotamine heparin in adult patients with open heart surgery (CABG) at ShahidRajaee Cardiovascular Research and Treatment Center
The purpose of this study was to investigate the effect on the amount of bleeding in patients and the relationship between ROTEM and protamine overdose
Design
The clinical trial has two groups of intervention and control, community-based, as well as two parallel groups, one-blind blind
Settings and conduct
Considering that one of the important aspects during the open heart surgery is the process of control
Coagulation of the patient in order to prevent blood clotting during surgery, and one of the most important
Our best criteria for deciding whether or not to start a patient's surgery
During surgery, one of the issues that affects the quality of the operation is the issue of hemorrhage, and this process should be monitored.
The site is the centerpiece of Shahid Rajaee Cardiology, Research and Therapy Center.
The method of this study is to examine the intervention and control groups during the operation. In the intervention group, the protocol is seeking to achieve the minimum amount of bleeding and complications due to inhibition of the coagulation mechanisms of the patient.
Participants/Inclusion and exclusion criteria
Patients who undergo surgery for the first time and have not received anticoagulant drugs are among our entrants.
Patients undergoing surgery for the second time or more, or coagulation disorders or receiving anticoagulants, are excluded from our study.
Intervention groups
In the intervention group, by analyzing the protocol for the neutralization of patient's coagulation pathways, we seek to reduce unwanted complications as well as unwanted bleeding during and after surgery so that we can have less costly surgery and fewer complications.
Main outcome variables
Check the amount of bleeding;Check the blood cell pack consumption; Assessing the length of hospitalization in the ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180719040524N1
Registration date:2019-07-23, 1398/05/01
Registration timing:retrospective
Last update:2019-07-23, 1398/05/01
Update count:0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Ali Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 7510
Email address
aliasghaffari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficiency and effectiveness of the ACT, ROTEM protocol for neutralizingprotamine heparin in adult patients with open heart surgery (CABG) at ShahidRajaee Cardiovascular Research and Treatment Center
Public title
The efficacy of neutralizing heparin by prothamine in cardiac open heart surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who do not have an anticoagulant drug
Patients undergoing surgery for the first time
Exclusion criteria:
Patients with a history of heart surgery
Patients with coagulation disorders
Patients with liver and kidney failure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients undergoing surgery are divided into two intervention and control groups that are divided into the knowledge of the medical staff as well as the patients between the two groups, so that the patients do not know which group they are divided into and after entering the operating room.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Pharmacy and Pharmaceutical Sciences, Islamic Azad University of Medica
Street address
No.24;38 street;shahr ara street
City
tehran
Province
Tehran
Postal code
144574429
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.IAU.PS.REC.1397.294
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I70
ICD-10 code description
Atherosclerosis
Primary outcomes
1
Description
To investigate more precisely the blood factors and the results of neutralizing the effects of anticoagulant drugs used during surgery, we use the ROTEM device.
Timepoint
At the end of the operation, if necessary, an observer will be used
Method of measurement
By ROTEM
2
Description
Our primary variable is the patient's activated clotting time (ACT)
Timepoint
ACT is taken from the beginning of the surgery every hour and ACT is taken at the end of the operation, after neutralizing the effect of heparin ACT.
Method of measurement
Measured by ACT
Secondary outcomes
empty
Intervention groups
1
Description
Our intervention group on the day of operation after taking the anesthetic is taken from the ACT patient at the start of the procedure, and then 3mg / kg heparin is given to prepare the patient for the pump to go. The ACT is acceptable to go to the 420-480sec pump. In order to ensure that this number is taken again, ACT is taken. The pump is also impregnated with 100 milligrams of heparin to prevent the possibility of blood coagulation in the pump ducts. After the patient goes to the pump half an hour later, we take another ACT. And then, depending on the duration of the action, if the discretion and necessity of every hour, an ACT is taken from the patient. At the end of the operation, when you want Let's warm the patient and bring her body temperature to 36.5 degrees from the ROTEM patient as well as the ACT before the pump is turned off. When the patient is transferred to the ICU (ACT), ACT is taken and one hour later if We look at the bleeding from the ROTEM patient in order to investigate the underlying cause. According to this protocol, we try to achieve the optimal dose of heparin and protamine and the dose of the two for the patient from the amount of unwanted bleeding at the end of the patient. Practicing and wasteful use of industrial products.
Category
Treatment - Surgery
2
Description
Control group: Our control group is selected on the basis of anesthesiologists' and epidemiologist's discretion and placed on the routine of the operating room under anesthesia and attached to the pump.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Heart Hospital
Full name of responsible person
Ali Ghaffari
Street address
End Of Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
aliasghaffari@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Heart Hospital
Full name of responsible person
Dr. Hooman Bakhshandeh
Street address
End of Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
aliasghaffari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?