The purpose of this study determination the effect of N acetylcysteine on coagulation tests (BT, PT) in patients with acute acetaminophen poisoning admitted to hospital. This research is conducted as a clinical trial and Interventional. N-acetylcysteine is the main treatment in patients with acute acetaminophen poisoning. 36 patients were enrolled, in all patient who were history of acute acetaminophen poisoning with toxic dose (>7.5gram), immediately administered N- acetylcysteine as the standard dose. All the subjects received 218.75 mg/ kg N acetylcysteine for 8 hours after the start of treatment and 268.75 mg/ kg N acetylcysteine for 16 hours after the start of treatment. Prothrombin time and bleeding time test is performed in three steps from each patient that first admission and before treatment with N-acetylcysteine, the next 8 hours after treatment with N-acetylcysteine and the latest 16 hours after initiation of treatment. It is necessary to investigate whether therapeutic dose of NAC (N-acetylcysteine) itself can cause falsely increased prothrombin time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061218070N1
Registration date:2015-07-26, 1394/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Soheila Sadat Vaghefi
Name of organization / entity
Shahidbeheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 5748
Email address
soheilavaghefi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of NAC's effect on coagulation tests (prothrombine time, Bleeding Time) in acute acetaminophen poisoning
Public title
Assessment of NAC's effect on coagulation tests in acute acetaminophen poisoning
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: the maximum time interval between consumption and arrive patient to hospital of 1-2 hours; acute acetaminophen poisoning; consumption more than 7.5 gram of acetaminophen; drugs containing acetaminophen without affecting liver function (adult cold); age of more than14 years.
Exclusion criteria: chronic acetaminophen poisoning; history of liver disease; history of Coagulopathy; coingestion; taking acetaminophen containing compounds with effects on liver function(eg.,acetaminophen codeine).
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St., Evin
City
Tehran
Postal code
Approval date
2013-02-03, 1391/11/15
Ethics committee reference number
0308/15696
Health conditions studied
1
Description of health condition studied
acute acetaminophen poisoning
ICD-10 code
x60
ICD-10 code description
Intentional self-poisoning by and exposure to nonopioid analgesics, antipyretics and antirheumatics
Primary outcomes
1
Description
Prothrombine time
Timepoint
Befor intervention, 8 hours after intervention, 16 hours after intervention
Method of measurement
Second, blood sample
2
Description
Bleeding time
Timepoint
Befor intervention, 8 hours after intervention, 16 hours after intervention
Method of measurement
Minute
Secondary outcomes
empty
Intervention groups
1
Description
In all patient who were history of acute acetaminophen poisoning with toxic dose (>7.5gram), immediately administered N - acetylcysteine as the standard dose. All the subjects received 218.75 mg/ kg N acetylcysteine for 8 hours after the start of treatment and 268.75 mg/ kg for 16 hours after the start of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poisoning center, Shohadaye Haft Tir hospital
Full name of responsible person
Dr. Mohammad Ali Emam Hadi
Street address
Shahre Rey, Rajayi avenue
City
Shahre Rey
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Science, Koodakyar Avenue,Yaman Avenue, Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Position
Associate Professor, Department of Forensic Medicine and Toxicology, Shahid Beheshti University of M
Other areas of specialty/work
Street address
Loghman hakim hospital, Kamali St., South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
mstzbmd@sbmu.ac.ir; mstzbmd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Position
Associate Professor, Department of Forensic Medicine and Toxicology, Shahid Beheshti University of M
Other areas of specialty/work
Street address
Loghman hakim hospital, Kamali St., South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
mstzbmd@sbmu.ac.ir; mstzbmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Babak Mostafazadeh
Position
Associate Professor, Department of Forensic Medicine and Toxicology, Shahid Beheshti University of M
Other areas of specialty/work
Street address
Loghman hakim hospital, Kamali St., South Kargar St.
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
mstzbmd@sbmu.ac.ir; mstzbmd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)