The effect of tranexamic acid on mortality and morbidity in spontaneous ICH patients
Design
This study is a double blind randomized clinical trial in Amir al-Momenin Hospital in Arak, Iran in 1398 with easy sampling method. This study is a double blind randomized clinical trial. All spontaneous ICH patients who meet the inclusion criteria will be assessed after completing the informed consent form as the study population. The responsible person is aware of the type of study and the study groups, while patients are not aware of the type of injectable drug.
Settings and conduct
This study was a double blind randomized clinical trial in Amir al-Momenin hospital in Arak. In this study 94 patients were randomly divided into two equal groups of placebo and tranexamic drug using block randomization method. Acids are divided
Participants/Inclusion and exclusion criteria
Arrival: Spontaneous ICH patients refer to emergency department of Arak Amir al-Momenin Hospital
Exclusion: 1. The patient is a candidate for surgery.
2. The patient has a history of documented cerebral venous thrombosis (CVT) and venous thrombosis.
Intervention groups
In the intervention group, 47 patients with ICH spontaneously receive 1 gram bolus in the first 10 minutes and receive 1 gram intravenous infusion in the first 8 hours. In the control group, 47 patients with spontaneous ICH receive normal saline, 1 g bolus in the first 10 minutes and 1 g intravenous infusion in the first 8 hours.
Main outcome variables
If there is a significant relationship between the administration of tranexamic acid in spontaneous ICH patients and the non-proliferation of intracerebral hematoma in these patients, further studies can confirm this important effect on the prognosis of these patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191014045103N1
Registration date:2019-11-23, 1398/09/02
Registration timing:prospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Omid Ezati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3422 6135
Email address
i.am.khodam.dg@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tranexamic acid on mortality and morbidity in spontaneously ICH patients
Public title
Effect of Tranexamic acid on mortality and morbidity in spontaneously ICH patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Spontaneous ICH Patients Refer to Emergency Department of Arak Amiralmomenin Hospital in Arak
Exclusion criteria:
The patient is a candidate for surgery
Patient with documented cerebral venous thrombosis (CVT) and documented venous thrombosis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized double-blind clinical trial study on 94 patients undergoing tranexamic acid injections who will divided into two equal groups using placebo and tranexamic acid by blocking randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study only the expert in charge of the study is aware of the type of study and study groups while patients are not aware of the type of injectable drug. Also, the intern in charge of the plan, which is responsible for filling in the checklist, is not aware of the type of injectable drug group and only knows the groups based on A and B and fills out the checklists accordingly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.ARAKMU.REC.1398.138
Health conditions studied
1
Description of health condition studied
Intracerebral hemorrhage
ICD-10 code
I61.0
ICD-10 code description
Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
After the injection
Method of measurement
Admitted by checklist as number of days hospitalization
2
Description
Evaluation of the patient's clinical condition
Timepoint
After the injection
Method of measurement
Checklist and NIHSS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 47 patients with spontaneous ICH receive tranexamic acid, 1 g bolus in the first 10 minutes and 1 g intravenous infusion in the first 8 hours. Patients are then assessed on the basis of a checklist including the number of days of hospitalization and clinical status based on the NHISS form.
Category
Treatment - Drugs
2
Description
Control group: 47 patients with spontaneous ICH receive normal saline as 1 gram bolus in the first 10 minutes and 1 gram intravenous infusion in the first 8 hours. Hospitalization and clinical status are assessed on the basis of the NHISS form.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Saeed Soltani
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Rsearch@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjmandzadegan
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Omid Ezati
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Taleghani blvd
City
Arak
Province
Markazi
Postal code
3881883517
Phone
+98 86 4622 9116
Fax
Email
i.am.khodam.dg@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Omid Ezati
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Taleghani blvd
City
Arak
Province
Markazi
Postal code
3881883517
Phone
+98 86 4622 9116
Fax
Email
i.am.khodam.dg@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Omid Ezati
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Taleghani blvd
City
Arak
Province
Markazi
Postal code
3881883517
Phone
+98 86 4622 9116
Fax
Email
i.am.khodam.dg@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available