Protocol summary

Study aim
Determining the effect of heparin concentration of 1000 units per ml in blood sample on venous blood gas results of patients admitted to intensive care unit
Design
clinical trial with control group, with parallel groups, one-way blind, on 282 samples by non-random sampling method and available
Settings and conduct
Intravenous blood samples are taken from 282 (n = 141 intervention group and n = 141 control groups) patients admitted to the intensive care unit of 22 Bahman Hospital in Neishabour. Syringes are placed in two groups of heparin 1000 units and heparin 5000 units. An equal number of insulin syringes will be heparinized by the researcher in one group (A) with 1000 units of heparin solution (0.5 cc) and the other group (B) with 5000 units of heparin with the same amount (0.5 cc) of heparin. (50 units per syringe) will be divided into two insulin syringes heparinized with codes A (heparin 1000 units) and B (heparin 5000 units) that only the researcher knows the nature of. Not given to the analyzer and the answers are compared with each other.
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study Patients admitted to the cardiac intensive care unit Age 60-18 years Hemoglobin level more than 10 mg per deciliter There coagulopathy or anticoagulant treatment of moderate to high dose Death or discharge from the ward
Intervention groups
An equal number of insulin syringes were heparinized in one group (intervention group) with 1000 units of heparin solution at a rate of 0.1 cc. In the control group, based on the current situation, an injection of 5000 units of heparin in the amount of 0.1 ml will be used to impregnate the insulin syringes used for blood sampling to perform venous blood gas tests.
Main outcome variables
Sodium, kalium, Calcium, PVO2, PVCO2, HCO3, buffer Base, Base Exese, PH

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200929048885N1
Registration date: 2020-10-19, 1399/07/28
Registration timing: registered_while_recruiting

Last update: 2020-10-19, 1399/07/28
Update count: 0
Registration date
2020-10-19, 1399/07/28
Registrant information
Name
Rasool Lakziyan
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 51 4262 3781
Email address
taha1992rajaei@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Heparin Concentration of 1000 units per ml in Blood Samples on the Results of Venous Blood Gases intensive care unit patients
Public title
The Effect of Heparin Concentration of 1000 units per ml in Blood Samples on the Results of Venous Blood Gases intensive care unit patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Patients admitted to the cardiac intensive care unit Age 60-18 years Hemoglobin level more than 10 mg per deciliter
Exclusion criteria:
There coagulopathy or anticoagulant treatment of moderate to high dose Death or discharge from the ward
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 141
More than 1 sample in each individual
Number of samples in each individual: 2
Syringes will be placed in two groups of heparin 1000 units (heparinized syringes with 1000 units) and heparin 5000 units (the common method of heparinized syringes with heparin is 5000 units). An equal number of insulin syringes will be heparinized by the researcher in one group (A) with 1000 units of heparin solution at the rate of 0.05 cc and the other group (B) with 5000 units of heparin with the same amount (0.05 cc). The blood sample was taken by the researcher at the rate of 1 cc from the peripheral venous line of each patient and the same blood prepared from one person in equal amounts (50 units or half a cc) in both syringes (B, A) that were already heparinized , Is distributed.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
First, all participants will be explained how to implement the project. The syringes will then be placed in two groups of heparin 1000 units (heparinized syringes with 1000 units) and heparin 5000 units (the common method of heparinized syringes with heparin is 5000 units). An equal number of insulin syringes will be heparinized by the researcher in one group (A) with 1000 units of heparin solution (0.05 cc) and the other group (B) with 5000 units of heparin with the same amount (0.05 cc). They will be divided equally by the researcher (0.5 cc or 50 units per syringe) into two insulin syringes heparinized with codes A (heparin 1000 units) and B (heparin 5000 units) that only the researcher knew about. It is then placed on ice and sent to the laboratory within 10 minutes, along with a test sheet that lists the necessary parameters (patient biography, body temperature, hemoglobin level, oxygen intake). A laboratory that does not know the amount of heparin in the syringes is given to the analyzer.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shaheed Rajaie Cardiovascular Medical and Research Center
Street address
Tehran - Vali Asr St. (AS) - next to Mellat Park - corner of Niayesh Educational, Research and Treatment Center
City
tehran
Province
Tehran
Postal code
1995614331
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.RHC.REC.1399.064

Health conditions studied

1

Description of health condition studied
heparin soduim
ICD-10 code
T45.9
ICD-10 code description
Primarily systemic and haematological agent, unspecified

Primary outcomes

1

Description
Pvo2
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

2

Description
Pvco2
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

3

Description
Hco3
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

4

Description
Buffer Base
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

5

Description
Base Exese
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

6

Description
PH
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

Secondary outcomes

1

Description
Sodium
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

2

Description
Kalium
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

3

Description
Calcium
Timepoint
Immediately after venous blood sampling
Method of measurement
Laboratory, venous blood gas meter

Intervention groups

1

Description
Intervention group: Dilute an equal number of insulin syringes in a group (intervention group) with 1000 units of heparin solution (to prepare 1000 units of heparin, dilute one ampoule of 5000 units of heparin with 4 cc of distilled water in a 5 cc syringe and its volume To 5 cc, each cc equal to 1000 units), heparinized to 0.1 cc.
Category
Treatment - Drugs

2

Description
Control group: In the control group, based on the current situation, an ampoule of 5000 units of 0.1 ml of heparin was used to impregnate the insulin syringes used for blood sampling to test venous blood gases.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
22 bahman hospital neyshabour
Full name of responsible person
rasool lakziyan
Street address
Noor .ST
City
neyshabour
Province
Razavi Khorasan
Postal code
1995614331
Phone
+98 51 4262 3781
Email
ccu1taha1992@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
fidan shabani
Street address
Tehran - Vali Asr St. - Next to Mellat Park - the beginning of Niayesh Highway
City
tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2340
Email
fidannahal@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaie Cardiovascular, Medical & Research Center
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
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
rasool lakziyan
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
noor ST
City
neyshabour
Province
Razavi Khorasan
Postal code
1995614331
Phone
+98 51 4262 3781
Email
ccu1taha1992@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
rasool lakziyan
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
noor ST
City
neyshabour
Province
Razavi Khorasan
Postal code
1995614331
Phone
+98 51 4262 3781
Email
ccu1taha1992@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
rasool lakziyan
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
noor.ST
City
neyshabour
Province
Razavi Khorasan
Postal code
1995614331
Phone
+98 51 4262 3781
Email
ccu1taha1992@gmail.com

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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...