Comparison of the Effectiveness of Thromboelstometry -Based Blood Management with Conventional Management in Blood and Blood Components Consumption in Patients Undergoing Combined Coronary- Valve Surgery
ٍEvaluation of the management of transfusion using thromboelastometry test in blood and blood product consumption
Design
Two arm parallel group randomized trial design of 80 patients; double blinded
Settings and conduct
Rajaie Cardiovascular Medical and Research Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients scheduled for combined coronary- valve surgery
Exclusion criteria: Patients with hereditary coagulopathy; Liver dysfunction; renal dysfunction; and redo surgery
Intervention groups
Rotem group: In this group transfusion conduct based on the thromboelastometry test results
Control group: In this group transfusion conduct based on the conventional coagulation tests results
Main outcome variables
Number of transfused RBC, Platlet and FFP units; Number of patients who transfused
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170705034908N2
Registration date:2018-08-27, 1397/06/05
Registration timing:retrospective
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Elham Khalaf Adeli
Name of organization / entity
High Institute for Education and Research in Transfusion Medicine,
Country
Iran (Islamic Republic of)
Phone
+98 88601582
Email address
adeli.elham@gmail.com
Recruitment status
Recruitment complete
Funding source
High Institute for Education and Research in Transfusion Medicine,, Rajaie cardiovascular medical and research center
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-08-22, 1396/05/31
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Thromboelstometry -Based Blood Management with Conventional Management in Blood and Blood Components Consumption in Patients Undergoing Combined Coronary- Valve Surgery
Public title
Effects of Thromboelastometry-Based blood management on transfusion in cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
َََAdult patients scheduled for elective combined coronary- valves surgery with CPB
Patients who have minimum hemoglobin 8 g/dl and Hematocrit 24, before surgery
Patients who have discontinued the anti-platelet drugs at least 5 days and Warfarin at least 3 days before surgery
Exclusion criteria:
Patients with hereditary coagulopathy
Patients with severe liver dysfunction
Patients with renal dysfunction
Patients with Redo surgery
Patients who are pregnant
Patients who are requiring emergency surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
ُStudy population will randomize to two groups using a computer generated randomization list. The method of randomization is balanced block .
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants and people who collect the data are blind about intervention groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of High Institute for Education and Research in Transfusion Medicine,
Street address
IBTO; Hemmat EXPY; Adjacent to Milad Tower
City
Tehran
Province
Tehran
Postal code
1157-14665
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.TMI.REC.1393.14
Health conditions studied
1
Description of health condition studied
Coronary-Valve surgery
ICD-10 code
197.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Number of transfused units of RBC, FFP, and Platelet
Timepoint
During surgery and 24 hours after surgery
Method of measurement
Count of the number of consumed bags
2
Description
Frequency of patients who transfused
Timepoint
During surgery and 24 hours after surgery
Method of measurement
Count of transfused patients using checklist
Secondary outcomes
empty
Intervention groups
1
Description
ّّFirst intervention group: Thromboelastometry tests including( Extem ، Intem، Heptem،Fibtem) will be performed in two time point ( before and after CPB) . Transfusion will be directed using a protocol based on the results of the thromboelastometry tests
Category
Other
2
Description
Control group: Patients will be transfused according to the routine practices in this center including conventional coagulation testing( PT, PTT, INR, fibrinogen, Platelet count) and clinical decision
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Elham Khalaf-Adeli
Street address
Mellat park, Vali-Asr Avenue,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
15745-1341
Phone
+98 21 2392 2154
Email
Adeli.elham@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
High Institute for Education and Research in Transfusion Medicine,
Full name of responsible person
Ali Akbar Pourfathollah
Street address
IBTO , Adjacent to Milad Tower, Hemmat EXPY, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1157-14665
Phone
+98 21 8860 1501
Email
info@ibto.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
High Institute for Education and Research in Transfusion Medicine,
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian Blood Transfusion Organization
Full name of responsible person
Ali Akbar Pourfathollah
Position
Ibto manager, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology, Transfusion medicine
Street address
IBTO, Adjacent to Milad Tower, Hemmat EXPY, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14665-1157
Phone
+218 8601582
Fax
Email
Pourfa@ibto.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
High Institute for Education and Research in Transfusion Medicine,
Full name of responsible person
Elham Khalaf Adeli
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Transfusion medicine
Street address
IBTO, Adjacent to Milad Tower, Hemmat EXPY, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1157- 14665
Phone
+218 8601582
Fax
Email
Adeli.elham@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Blood Transfusion Organization
Full name of responsible person
Elham Khalaf Adeli
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Transfusion medicine
Street address
IBTO; Hemmat EXPY; Adjacent to Milad Tower
City
Tehran
Province
Tehran
Postal code
14665-1157
Phone
+98 912 530 1377
Fax
Email
Adeli.elham@gmail.com
Web page address
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