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Comparison of Two Dosing Nomograms of Heparin in Patients with Acute Coronary Syndrome (ACS) Hospitalized in the Cardiac Care Unit (CCU)

Protocol summary

Summary
The aim of this study is to compare two prevalent dosing nomograms of unfractioned heparin. Patients with acute coronary syndrome (ACS) hospitalized in the Cardiac Care Unit (CCU) of two university affiliated hospitals will be enrolled. Inclusion criteria are age >18 years, ACS, admission to CCU and exclusion criteria are receiving thrombolytic drugs in the past week, current bleeding, history of thrombocytopenia with heparin, receiving heparin prior to hospitalization, and thrombocytopenia. The first person that is admitted to the study randomly receives an even or odd number. Afterward, each subject gets either an odd or even number, consecutively. Patients with even number will be allocated in group 1 and individuals with odd number will receive heparin based on nomogram 2. This will be continued until number of patients in each group will be at least 70. Prior to commencing heparin infusion, aPTT and platelets are measured. Heparin will be given based on one of the nomograms and aPTT is controlled every 6 hours for at least 48 hours. Group 1 receives a bolus of 80 U/Kg/hr and an initial infusion rate of 17 U/Kg/hr. In the second group, a bolus of 60 U/Kg (maximum 4000 U) and an initial infusion rate of 12 U/Kg/hr (maximum 900U/hr) is given. Then, every 6 hours, rate of heparin will be changed based on aPTT results and the nomogram. Primary outcome is reaching therapeutic aPTT (46-70 s), and secondary outcomes are time to reach therapeutic aPTT and number of adjustments in the rate of heparin.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138708111221N2
Registration date: 2011-07-12, 1390/04/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-12, 1390/04/21
Registrant information
Name
Mahdieh Namayandeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1523 1421
Email address
hrc@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Dosing Nomograms of Heparin in Patients with Acute Coronary Syndrome (ACS) Hospitalized in the Cardiac Care Unit (CCU)
Public title
Comparison of Two ِDosing Nomograms of Heparin in Patients with Acute Coronary Syndrome (ACS) Hospitalized in the Cardiac Care Unit (CCU)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: >18 years old; ACS; admission to CCU. Exclusion criteria: receiving thrombolytic drugs in the past week; current bleeding; history of thrombocytopenia with heparin; receiving heparin prior to hospitalization; thrombocytopenic patients.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadooghi blvd
City
Yazd
Postal code
8916978477
Approval date
2006-02-16, 1384/11/27
Ethics committee reference number
42926

Health conditions studied

1

Description of health condition studied
acute coronay syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified

Primary outcomes

1

Description
aPTT in the therapeutic range (46-70 s)
Timepoint
before infusion of heparin and every 6 hours until 48 hours after intervention
Method of measurement
standard methods of measuring aPTT

Secondary outcomes

1

Description
number of changes in the rate of heparin
Timepoint
every 6 hours until 48 hours after intevention
Method of measurement
observation

2

Description
time to reach therapeutic aPTT
Timepoint
every 6 hours until 48 hours after intevention
Method of measurement
measuring time by watch

Intervention groups

1

Description
Patients in group 1 receive a bolus of 80 U/Kg and an initial infusion rate of 17 U/Kg/hr. APTT is controlled every 6 hours for 48 hours. The therapeutic level of aPTT is 46-70 s. If aPTT is in this range, no intervention will be done. But if aPTT is 35-46 s, rate of infusion will be increased by 2 U/kg/hr and for aPTTs<35 s, rate will be raised by 4 U/kg/hr. If aPTT is 71-90 s or>90 s, the rate of heparin will be decresed by 2 or 3 U/kg/hr, respectively.
Category
Treatment - Drugs

2

Description
Patients in the second group receive a bolus of 60 U/Kg (maximum 4000 U) and an initial infusion rate of 12 U/Kg/hr (maximum 900U/hr). aPTT is measured every 6 hours up to 48 hours. For aPTT,46-70 s, no change in the rate will be done. But if aPTT is <46s, the rate will be increased by 2U/kg/hr. If aPTT is 71-80 s, 81-90 s, or >90 s, the rate of heparin will be decreased by 1, 2, or 3 U/kg/hr, respectively.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd cardiovascular reaserch center
Full name of responsible person
Sedigheh Bagheri
Street address
Afshar hospital, Jomhoori blvd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Tahereh Rahimdel
Street address
Shahid Sadooghi blvd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Yazd cardiovascular research center
Full name of responsible person
Roghieh Atashkooh
Position
Resposible of research services/diploma
Other areas of specialty/work
Street address
Afshar hospital, Jomhoori blvd
City
Yazd
Postal code
8917945556
Phone
+98 35 1523 1421
Fax
+98 35 1523 1421
Email
yazdheartcenter@gmail.com
Web page address
http://www.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Moneyreh Modares Mosadegh
Position
lecturer/pharm.D
Other areas of specialty/work
Street address
Afshar hospital, Jomhoori blvd
City
Yazd
Postal code
8917945556
Phone
+98 35 1820 3419
Fax
+98 35 1820 3418
Email
mo_modares@yahoo.com
Web page address
http://www.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
cardiovascular research center
Full name of responsible person
Mahdieh Namayandeh
Position
Reseach manager
Other areas of specialty/work
Street address
Jomhoori blvd
City
Yazd
Postal code
8917945556
Phone
+98 35 1523 1421
Fax
+98 35 1523 1421
Email
drnamayandeh@gmail.com
Web page address
http://www.ssu.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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