Protocol summary

Summary
The aim of this study is to investigate the effect of celox powder in decreasing time to hemostasis of vascular punctures site in hemodialysis patient. in 67 dialysis patients three time in week (with interval of 48 hours) time to hemostasis of fistula of puncture site measurement and average of this three sessions determined as the time to hemostasis of arteriovenous fistula for per patient. The patients who Time to hemostasis was eight minuts or more of eight minutes selected with sampling rely on purpose .then per puncture site of arteriovenous fistula in three separated week( Per week ,in two consecutive sessions) ,in first week with routine dress gram celox powder and in third week with use of 0.5 gram celox powder treatment. Time to Hemostasis for per punctur site in three method Measurmented and recorded and analysed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072813968N2
Registration date: 2014-02-02, 1392/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-02, 1392/11/13
Registrant information
Name
Mahmood Choubdar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 2825 3145
Email address
choubdarm891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2013-04-13, 1392/01/24
Expected recruitment end date
2013-06-29, 1392/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of celox powder and conventional gauze dressing on time to hemostasis of vascular access in hemodialysis patients
Public title
The effect of celox powder on hemostasis of vasscular access in hemodialysis pateint.
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Have consent for participant in study; three time in week treatment with hemodialysis ; vascular access is fistful; age of 18-75 ; Time to hemostasis 0f vascular puncture site is eight minutes or more of eight minutes. Exclusion criteria:Not Orient to place, person and time ; have coagulopathy problem and abnormal bleeding.
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: 11
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical Science
Street address
Ghoraishy Building, University St, Mashhad
City
Mashhad
Postal code
Approval date
2013-02-28, 1391/12/10
Ethics committee reference number
911055

Health conditions studied

1

Description of health condition studied
hemodialysis
ICD-10 code
z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
hemostasis
Timepoint
till to hemostasis
Method of measurement
cronometr

Secondary outcomes

1

Description
Rebleeding
Timepoint
After 48 hours
Method of measurement
Quational form

2

Description
alergy
Timepoint
After 48 hours
Method of measurement
Quational form

Intervention groups

1

Description
The first week :In two consecutive sessions with removaling of needles،one regular gauze with diameter and wide 2/5 centimeter placement in site of removal of needles and mild manually pressure apply. per two minutes , punctures site look for hemostasis.Time to hemostasis account for per punctur. the more time, record for patient of hemostasis time.
Category
Treatment - Other

2

Description
The second week: in two consecutiv session, 1 gram celox powder pour on gauze with diameter and wide 2/5 cm and with removaling of needles placement in site of removal of needles and mild manually pressure apply.per two minutes ,punctures site look for hemostasis.Time to hemostasis account for per punctur . the more time recorded for patient omosf hetasis time.
Category
Treatment - Drugs

3

Description
The third week: As the second week but half gram of celox powder used
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hamid Chamanzari
Street address
Emamreza Hospital , Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Jalil Tavakol Afshari
Street address
Ghoraishy Building, University St, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences Vice chancellor for research
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
Mashhad university of Medical
Full name of responsible person
Mahmood Choubdar
Position
Critical care Nursing Arshad Expert student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
choubdarm891@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of Medical
Full name of responsible person
Hamid Chamanzari
Position
Nursing Arshad Expert
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
chamanzarih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of Medical
Full name of responsible person
Mahmood Choubdar
Position
Critical Care Nursing Arshad Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing, Mashhad.
City
Mashhad
Postal code
3216-913791
Phone
+98 51 1859 1511
Fax
Email
choubdarm891@mums.ac.ir
Web page address
web@mums.ac.ir

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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