Comparison of the effect of heparin saline and normal saline on keeping open the pathway of peripheral or peripheral venous catheters in cancer patients
Comparison of the effect of heparin saline and normal saline on keeping open the pathway of peripheral or peripheral venous catheters in cancer patients
Design
Clinical trials with control group, with parallel, single blind, randomized clinical trials
Settings and conduct
5000 heparin units dissolved in one liter of normal saline solution, thereby diluting heparin. Then three cc of normal saline heparin and three cc of normal saline will be poured into niche bottles in perfectly similar bottles. After sampling and dividing the samples into two groups of normal saline (group A) and normal heparin saline (group B), randomized intervention will be started. When nurse prescribes, the nurse will put three cc of the solution given with a 5 cc syringe into the catheter.The study will be conducted at Imam Reza Hospital in Tabriz, and the researcher will be blind to intervention groups.
Participants/Inclusion and exclusion criteria
Having cancer
Needed insertion of intravenous catheters
Intervention groups
5000 heparin units dissolved in one liter of normal saline solution, thereby diluting heparin. Then 3cc of normal saline heparin and 3cc of normal saline will be poured into niche bottles in perfectly similar bottles. When nurse prescribes, the nurse will put 3cc of the solution given with a 5 cc syringe into the catheter.
Main outcome variables
Phlebitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N4
Registration date:2019-05-21, 1398/02/31
Registration timing:prospective
Last update:2019-05-21, 1398/02/31
Update count:0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of heparin saline and normal saline on keeping open the pathway of peripheral or peripheral venous catheters in cancer patients
Public title
Methods of keeping the path of intravenous catheters open
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having cancer
Need to receive drugs through intravenous catheters
Exclusion criteria:
Patients with severe infectious disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are simply randomized to two groups , through random number table; received a special code and are treated with own group
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher will be unaware of how the patients are grouped and the type of intervention performed for each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.TBZMED.REC.1398.009
Health conditions studied
1
Description of health condition studied
Phlebitis
ICD-10 code
K75.1
ICD-10 code description
Phlebitis of portal vein
Primary outcomes
1
Description
Phlebitis
Timepoint
Every day at 12 o'clock
Method of measurement
Phlebite questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the nurse will administer the medicine, the nurse will put 3cc of the heparin saline solution into the catheter with a 5-cc syringe and then record the symptoms.
Category
Prevention
2
Description
Control group: Before the nurse will administer the medicine, the nurse will put 3cc of the normal saline solution into the catheter with a 5-cc syringe and then record the symptoms.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dara Alvandfar
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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