Protocol summary

Summary
The present study is a double-blind randomized (patient and researchers) clinical trial. The aim of this study was to determine and compare the effects of heparin 1000 and 5000 units on arterial blood gas findings with inclusion criteria, willingness to participate in The study was suitable for appropriate arterial blood supply, aged 18 to 70 years, traumatic patients undergoing mechanical ventilation up to one week, and exclusion criteria, inadequate blood supply to the site of bleeding, lesion or surgical shunt ( Presence of fistula in that limb), evidence of peripheral vascular disease in the area around the hand of the site of bleeding, the presence of coagulopathy or counter-treatments Moderate to high doses, other patients hospitalized in other parts, active infection in the arterial pathway, and any damage to the organs including fracture, dislocation, and burn, deterioration of the patient, death or discharge from the department, and trauma of the shelf Breast in the intensive care unit of the Shahid Beheshti Hospital, Sabzevar University of Medical Sciences in 1396 will be performed. In this study, arterial blood samples were collected from 152 samples (n = 76, n = 76, control group) from the research community. Blood samples were equally distributed (50 units) in two 100-unit insulin syringes impregnated with 1000 and 5000 heparin units, and then the samples were sent to the lab, after receiving the answer, compared with each other. In this study, the measured variables included heparin 1000 units, heparin 5000 units, and, PH, Pao2, Paco2, Hco3, BEe, Beb, Na, Ca, K.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091836266N1
Registration date: 2017-10-28, 1396/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Reza Borabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 0115
Email address
borabadir95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
" Sabzevar University of Medical Sciences"
Expected recruitment start date
2017-10-27, 1396/08/05
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The Effect of Heparin Density unit 1000 with 5000 in Blood Sampling on the Results of Arterial Blood Gases in Intensive care unit in hospitals of sabzevar city in 1396.
Public title
Evaluation The Effect of Heparin Density unit 1000 with 5000 in Blood Sampling on the Results of Arterial Blood Gases in Intensive care unit in hospitals of sabzevar city in 1396.
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria Inclination to participate in appropriate blood flow to the affected arteries 18 to 70 years of age Patients underwent trauma under mechanical ventilation up to one week Standard for insufficient bleeding in the blood collection site Lesion or surgical shunt (presence of fistula in it Limb) evidence of peripheral vascular disease in the surrounding area of the cochlear region Coagulopathy or anticoagulant treatment with a moderate to high dose of other patients admitted to other parts of the body Active infection in the arterial pathway and any damage to the limbs include: fracture, dislocation, and Death burn or deterioration of the chest trauma section
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Sabzevar, Towhid Town
City
Sabzevar
Postal code
Approval date
2017-08-13, 1396/05/22
Ethics committee reference number
IR.MEDSAB.REC.1396.62

Health conditions studied

1

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

Primary outcomes

1

Description
Heparin 1000 unit
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

2

Description
Sodium
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

3

Description
Kalium
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

4

Description
Calcium
Timepoint
Onse
Method of measurement
lab Test

5

Description
Pao2
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

6

Description
Paco2
Timepoint
Onse
Method of measurement
lab Test

7

Description
Hco3
Timepoint
Onse
Method of measurement
lab Test

8

Description
Buffer Base
Timepoint
Onse
Method of measurement
lab Test

9

Description
Base Exese
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

10

Description
pH
Timepoint
One day on the first day, the second day, the third day
Method of measurement
Laboratory, arterial blood gas meter

Secondary outcomes

1

Description
Heparin 5000 unit
Timepoint
one day, second day,
Method of measurement
Laboratory, arterial blood gas meter

Intervention groups

1

Description
Equalize insulin syringes (manufactured by Iran Medical Company) with a 1000-heparin solution (for intervention group) for 1000 heparin units. One heparin injection of 5000 units of the Alborz Drug Company with four cc distilled water in one The 5-cc syringe of the Iran-Tehran Medical Product was diluted and delivered to the 5 th cc, of which every thirty thousand equals 1,000 units), at 0.1 Ml heparinized.
Category
Treatment - Drugs

2

Description
In the control group, based on the status quo, heparin ampoules of 5,000 units were found to be 0.1ml To insert the insulin syringes used for blood sampling, arterial blood gas was used
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Relief Hospital, West Razi Street, Sabzevar
Full name of responsible person
Reza Borabadi
Street address
No. 9, Fayyaz 6, Fayyaz Street,Sabzevar
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammad Zadeh
Street address
Sabzevar University of Medical Sciences, Towhid Town Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
IR. MEDSAB.REC.1396.62
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences, Sabzevar Towhid Town
Full name of responsible person
Reza BORABADI
Position
Nursse in intensive care unit
Other areas of specialty/work
Street address
Shahid Beheshti Relief Hospital, West Razi Street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
http://mail.medsab.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences, Sabzevar Towhid Town
Full name of responsible person
Reza Borabadi
Position
Masters student
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Towhid Town Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
http://mail.medsab.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences, Sabzevar Towhid Town
Full name of responsible person
Reza Borabadi
Position
Masster Student
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences, Towhid Town Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4464 0115
Fax
Email
http://mail.medsab.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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