Protocol summary

Summary
This study aimed at comparing the effect of two blood taking methods namely venipuncture and saline lock on the results of blood routine tests obtained from the CCU hospitalized patients conducted non randomly and unicentral without control group on a number of 80 CCU hospitalized patients in pedagogical hospital in Zahedan. The criteria for entering the study included that the patients age must range from 35 to 70, they are required to do CCU routine tests according to the physicians’ order. They should not have any deformity on upper limbs. The exclusion criteria included lack of having suitable vein for catheter insertion and saline lock fixation and failure in taking blood from saline lock for the first time sampling. The intended interventions were conducted after the physician’s visit from 8 to 11 in the morning through blocking a tourniquet and after removing 0.5 ml of blood in the dead space of saline lock. The amount of five ml of blood was considered for the intended test. The same amount of blood was taken ordinarily from the opposite hand simultaneously as a control. The amount of CBC , ESR , CRP, BUN, Cr, Na, K, TG, Cholesterol, FBS , CPK, CKmb, LDH, PT, PT were compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030126858N1
Registration date: 2016-03-22, 1395/01/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-22, 1395/01/03
Registrant information
Name
Toktam Kianian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1415
Email address
drnm@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-01-26, 1393/11/06
Expected recruitment end date
2015-04-26, 1394/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of two blood taking methods namely, venipuncture and saline lock, on the results of routine blood tests obtained from the CCU hospitalized patients in Ali Ibn Abi Talib Hospital of Zahedan University of Medical Sciences in 2015.
Public title
The Effect of taking blood from a venipuncture and saline lock on the blood tests
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The patient’s age must range from 35 to 70. They are required to do routine tests of CCU based on the physicians’ order. There should be lack of clinical jaundice and lack of massive hemorrhage such as gastro-intestinal tract bleeding. There should exists Stable hemodynamic status and no sign of pregnancy in female patients. Lack of deformity in both upper limbs (as hemodialysis patients have shunts or Fistula or have mastectomy) is required as well. Exclusion criteria: Hematocrit (less than 25% or more than 60%); Anemia (Hemoglobin less than 12 gm/dl in females and less than 14 gm./dl in males; Coagulating disorders such as thrombocytopenia; Not having safe and healthy suitable vein for catheter insertion and Saline lock fixation; Failure in taking blood from saline lock for first time sampling.
Age
From 34 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Mashahir Square, School of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Approval date
2014-01-29, 1392/11/09
Ethics committee reference number
6234

Health conditions studied

1

Description of health condition studied
cardiovascular patients
ICD-10 code
I20, I21,
ICD-10 code description
Angina pectoris, Acute myocardial infarction, Subsequent myocardial infarction,Certain current complications following acute myocardial infarction, Other acute ischaemic heart diseases, Chronic ischaemic heart disease, Heart failure, Chronic Ischaemic He

Primary outcomes

1

Description
BUN
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

2

Description
CBC
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

3

Description
CRP
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

4

Description
ESR
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

5

Description
Na
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

6

Description
Cr
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

7

Description
K
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

8

Description
TG
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

9

Description
Cholesterol
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

10

Description
FBS
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

11

Description
CPK
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

12

Description
CKmb
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

13

Description
LDH
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

14

Description
PT
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

15

Description
PTT
Timepoint
Taking blood from Saline Lock and immediately from vein
Method of measurement
Laboratory experiment

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: Taking 5 cc blood from the patient’s opposite hand vein
Category
Other

2

Description
Intervention group: Taking 5 cc blood from the patients’ saline lock
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital
Full name of responsible person
Hamide Samadzade
Street address
Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatihe Kerman Saravi
Street address
School of Nursing and Midwifery
City
Zahedan
Grant name
1
Grant code / Reference number
6234
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
University of Medical Sciences
Full name of responsible person
Zahra Piashkarmofrad
Position
instructor
Other areas of specialty/work
Street address
Mashahir Square, School of Nursing and Midwifery
City
Zahedan
Postal code
00989151902115
Phone
+98 54 3341 1415
Fax
+98 54 3343 8473
Email
t.kianian67@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
toktam Kianian
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Zahedan
Postal code
Phone
+98 54 3341 1515
Fax
+98 54 3343 8473
Email
t.kianian67@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Toktam Kianian
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Zahedan
Postal code
Phone
+98 54 3322 0640
Fax
Email
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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