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Assessment of the effect of three heparinization methods of hemodialysis set on coagulation condition and dialysis efficacy in 25 patients under hemodialysis in Fateme Zahra Hospital Mehriz(1392)

Protocol summary

Summary
In this clinical trial study 25 patients of ESRD under hemodialysis in Fateme Zahra Hospital Mehriz Yazd in 1392, by purpose to recognize the best methods of Dialysis set heparinization, is assessed and heparinated by one of three methods of heparinization(1 - 2500u heparin stat and two times 200cc N/S infusion 2 -2000u heparin stat and 1000u/h to 1hr before end of dialysis 3 -2500u heparin stat and 2500u 2hr later ) .The PTT and UREA is checkek before and after of dialysis and assessed the different in two stages.The clot measurement is evaluated by one of four degree (no clot:o - low clot:1 - moderate clot:2 - severe clot:3 )in end of dialysis.This patients must be tolerated 4 hr Dialysis and have not coagulation problems or blood transfusion from one week ago.For assessment of dialysis efficacy and coagulation condition PTT and UREA will check and compare before and after of dialysis .Coagulation scale is (no clot;no evidence of clot in dialysor,low clot:clot in 1/4 diameter of dialysor,moderate clot:clot in 1/4 to 1/2 diameter of dialysor,severe clot:clot in above of 1/2 diameter of dialysor). Assessment of clot will be reliable because the clot will observe by one person.Sampling,speed of dialysis,method of access,kind of dialysor,dialysis solution,temperature,hydration,system of dialysis machine,dialysis set ,... for whole samples is equal.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021712498N1
Registration date: 2013-08-12, 1392/05/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-12, 1392/05/21
Registrant information
Name
Habib Ollah Babaei Baghdad Abadi
Name of organization / entity
Fateme Zahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 35 2522 3001
Email address
habib.babaei49@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi Yazd University Of Medical Science
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2013-07-01, 1392/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of three heparinization methods of hemodialysis set on coagulation condition and dialysis efficacy in 25 patients under hemodialysis in Fateme Zahra Hospital Mehriz(1392)
Public title
Effect of three heparinization methods of hemodialysis set on coagulation condition and dialysis efficacy in patients under hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age above 14 years;End Stage Of Renal Disease disorder certificated by nephrologist;No coagulative disorder(Hemophilia; DIC);No oral anticoagulation drugs(Aspirin;Warfarin);No clinical symptoms of Infection ,No Blood transfusion from one week ago ,No susceptible to bleeding by assessment PTT (normal range 25-35 second before Dialysis) , Exclusion criteria: Acute Renal Failure;Emergency dialysis; Dialysis by shunt access;Hepatitis type B & C ; Guess patients;Intolerance of dialysis(severe hypotension;hemorrhagia) blood transfusion;Cancer
Age
From 14 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd Shahid Sadughi University Of Medical Sciences
Street address
Central Building, Bahonar SQ
City
Yazd
Postal code
89819
Approval date
2013-04-29, 1392/02/09
Ethics committee reference number
20261

Health conditions studied

1

Description of health condition studied
Chronic Renal Failure
ICD-10 code
N 17 - N 1
ICD-10 code description
Acute Renal Failure_ Unspecified Kidney Failure

Primary outcomes

1

Description
clot
Timepoint
after dialysis time
Method of measurement
check list,clot observation

2

Description
Dialysis Efficacy
Timepoint
Before and after of Dialysis
Method of measurement
Urea test an check list

3

Description
PTT measurement
Timepoint
before and after of dialysis
Method of measurement
PTT test and check list

Secondary outcomes

1

Description
clot
Timepoint
in time& end of dialysis
Method of measurement
check list ,PTT measurement by autoanalyser BT 3000,, Urea measurement by autoanalyser BT 3000

Intervention groups

1

Description
Heparin injection by method:2500u stat before Dialysis in Arterial line and two times infusion 200cc N/S in Dialysis set .Each person is compared by own in the else method.
Category
Prevention

2

Description
Heparin injection by method:2000u stat before Dialysis in Arterial line & 1000u/h heparin drip by pump to 1 hour before end of dialysis. Each person is compared by own in the else method.
Category
Prevention

3

Description
Heparin injection by method: 2500u stat in Arterial line & 2500 u 2 hours laterin Arterial line.Each person is compared by own in the else method.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehriz Fateme Zahra Hospital
Full name of responsible person
Habib Ollah Babaei Baghdad Abadi
Street address
Fateme Zahra Hospital, Mehriz, Yazd
City
Mehriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sُُhahid ُSadughi University Of Medical Sciences, Mehriz, Fateme Zahra Hospital
Full name of responsible person
Habib Ollah Babaei Baghdad Abadi
Street address
No 9 Bustan, Waliasr Shahrak,mehriz
City
Mehriz
Grant name
Grant code / Reference number
20261
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sُُhahid ُSadughi University Of Medical Sciences, Mehriz, Fateme Zahra Hospital
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
Fateme Zahra Hospital, Mehriz )
Full name of responsible person
Habib Ollah Babaei Baghdad Abadi
Position
Head Nurse
Other areas of specialty/work
Street address
Emergency Ward, Fateme Zahra Hospital
City
Mehriz
Postal code
8981995933
Phone
+98 35252230015
Fax
+98 35 2522 3005
Email
habib.babaei49@gmai.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fateme Zahra Hospital
Full name of responsible person
Habib Ollah Babaei Baghdad Abadi
Position
Registered Nurse
Other areas of specialty/work
Street address
9 Bustan Waliasr Shahrak
City
Mehriz
Postal code
8981995933
Phone
+98 35 2522 1922
Fax
+98 35 2522 3005
Email
habib.babaei49@gmail.com
Web page address
www.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Fateme Zahra Hospital
Full name of responsible person
Habib Ollah Babaei Baghdad Abadi
Position
Registered Nurse/Head Nurse
Other areas of specialty/work
Street address
9 Bustan Waliasr Shahrak
City
Mehriz
Postal code
8981995933
Phone
+98 35 2522 1922
Fax
+98 35 2522 3005
Email
habib.babaei49@gmail.com
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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