Confirmation of the role of fibrinogen and fresh frozen plasma in improving the outcome of patients with multiple traumatic hemorrhagic shock
Design
A clinical trial study (Phase III) was administered to control, randomized, double blinded patients.
Sample size: 30 people (in each group ten).
Randomized block randomization and block size are considered equal to 4.
There are two intervention groups (A, B) and an active control group (C).
Group C will receive Packed Cell, Group B, Frozen Fresh Flask and Group A Fibrinogen.
Settings and conduct
Location: Emergency hospital of Golestan and Imam Khomeini hospitals in Ahvaz city.
Blindness: After evaluating an emergency medicine specialist or resident of the third year of emergency medicine residing in the CPR room and determining the placement of the patient in one of the three study groups, the prescribing instruction will be given to the nurse of the CPR department, and then the order of evaluation of the patient's vital signs will be given to the researcher. (Resident of Emergency Medicine) who has no information about how to describe the patient's placement and the type of injectable medicine to the patient.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with hemorrhagic shock caused by multiple trauma
Age> 14 years
Systolic blood pressure <90 mm Hg
Exclusion Criteria:
Pregnancy
Patients with known coagulopathy
Taking anti-coagulant drugs and antiplatelet drugs
Other causes of shock, such as neurogenic shock
Dissatisfaction of patient or patient companions to participate in the study.
Intervention groups
Control group: Patients receiving Packed Cell
intervention group 1: patients receiving fresh frozen plasma
intervention group 2: Patients receiving fibrinogen
Main outcome variables
Blood pressure; pH level; Oxygenation index; Multiple organ failure; Hospital duration; Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150704023046N4
Registration date:2020-02-08, 1398/11/19
Registration timing:retrospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Mehdi Gholamzadeh Baeis
Name of organization / entity
Qom Branch Of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 8586
Email address
dr.m.gholamzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the fibrinogen and fresh frozen plasma efficacy in patients outcome with hemorrhagic shock due to multiple trauma
Public title
Effect of fibrinogen compared to fresh frozen plasma on patients with hemorrhagic shock
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hemorrhagic shock caused by multiple trauma
Age> 14 years
Systolic blood pressure <90 mm Hg
Significant chance of bleeding
Evidence of intra abdominal bleeding
Clinical judgment of the doctor about the receipt of blood products
Exclusion criteria:
Pregnancy
Patients with known coagulopathy
Using anti-coagulant and anti-platelet drugs
Other causes of shock, such as neurogenic shock
Previous history of blood product in the last 6 months
Patients are severely ill, whose priority is to preserve the patient's health
Dissatisfaction with the patient or patient companions to participate in the study
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental randomization was done using randomized blocking method in which subjects were assigned to three main groups (two intervention groups and one control group) (each group was 10) and the volume of blocks was 4 Which was determined through the PROC PLAN in SAS 9.2 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness in this study is that after evaluating an emergency medicine practitioner and determining the patient's placement in one of our three study groups, the injectable drug will be given to the nurse of the CPR department, and then the order of assessment of the patient's vital signs will be researcher Emergency medicine), which has no information on how to describe the patient's placement and type of injectable medicine, is given according to the protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur Research and Technology Dept, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-08-29, 1397/06/07
Ethics committee reference number
IR.AJUMS.REC.1397.334
Health conditions studied
1
Description of health condition studied
Hemorrhagic shock
ICD-10 code
R58
ICD-10 code description
Hemorrhage, not elsewhere classified
2
Description of health condition studied
Hypovolemic shock
ICD-10 code
R57.1
ICD-10 code description
Hypovolemic shock
Primary outcomes
1
Description
Blood Pressure
Timepoint
4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day
Method of measurement
Clinical examination and assessment of vital signs by cardiac monitoring and pulse oximetry located in the cardiopulmonary resuscitation room
2
Description
Oxygenation index
Timepoint
4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day
Method of measurement
pulse oximetry located in the cardiopulmonary resuscitation room
3
Description
PH level
Timepoint
4 and 12 hours after admission, 24-hour short-term prognosis, 7-day mid-term and long-term 28-day
Method of measurement
By taking arterial blood samples and evaluating arterial blood gas by laboratory tests
4
Description
Duration of admission
Timepoint
When ordering a patient's discharge or issuing a death certificate
Method of measurement
Clinical examination and evaluation of patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving Packed Cell and Frozen Fresh Plasma in proportion (FFP: 1: 1 PRbc Ratio). Intervention is performed for each patient at one time in the emergency CPR room. Each packed cell is approximately 200-250 cc and each frozen plasma unit is 200-300 cc.
Category
Treatment - Drugs
2
Description
Intervention group: Patients receiving Packed Cell and Fibrinogen. The amount of fibrinogen injection will be 70 mg / kg. The fibrinogen vial is made in Germany and will be provided by Avin Daru Company in Iran. Interventions are performed for each patient at one time and in the emergency CPR room.
Category
Treatment - Drugs
3
Description
Control group: Patients receiving Packed Cell. The Packed Cell available at the Blood Bank Center of the studied hospitals was used. The size of each Packed Cell is approximately 200-250 cc. The number of Packed Cell varies depending on the patient's needs and clinical conditions. Intervention is performed for each patient at one time and in the emergency CPR room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Ahvaz City
Full name of responsible person
Ehsan Karimpour
Street address
Golestan Medical Center - Farvardin Avenue - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3337 4058
Email
Golestanhospital@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz City
Full name of responsible person
Ehsan Karimpour
Street address
Imam Khomeini Hospital, Ahvaz Medical Center - Azadegan Avenue
City
Ahwaz
Province
Khouzestan
Postal code
61936-73111
Phone
+98 61 3222 2114
Email
Himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Ahvaz Jundishapur University of Medical Sciences - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Karimpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
Dr.EhsanKarimpour@Gmail.Com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Meysam Moezi
Position
Assistent professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
Dr.EhsanKarimpour@Gmail.Com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Karimpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Ahvaz Jundishapur University of Medical Sciences - Golestan
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
Dr.EhsanKarimpour@Gmail.Com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and academic institutions and industry-related people
Under which criteria data/document could be used
Solely for the sake of scientific use and only with the permission of the owners of the design
From where data/document is obtainable
Responsible person is responsible for studying and by email registered on the site
What processes are involved for a request to access data/document
So coordinate with the responsible person responsible for the study through email registered on the site