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The effect of Tranexamic acid administration on non-traumatic Intracerebral hemorrhage in contrast with placebo in Namazi hospital.

Protocol summary

Study aim
comparison between Tranexamic acid and Placebo effect on treatment of cerebral intra-paranchymal hemorhage in Namazi hospital.
Design
A concealed, randomized, single-blinded, sham-controlled clinical trial with a parallel group design of 100 patients, enroll between 2020 and 2021 and follow for 6 mounts. Randomization in eligible patients will be carried out via permuted block randomization with10 blocks that include 10 numbers.
Settings and conduct
In this study, patients with intraparanchymal hemorrhage will be participated who admitte in Namazi hospital. In this Single blinded study, patients will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-75 years old, acute intraparanchimal hemorrhage(within last 12 hours) without history of truama. Exclusion criteria: multiple intraparanchimal hemorrhage, contraindication for antifibrinolytic use, massive intraparanchimal hemorrhage (>70cc), brain stem hemorrhage, anurysem, vascular malformation, hemorrhagic transformation after stroke, Cerebral venous thrombosis, thrombolytic therapy, brain tumors, infections, cranial surgery within 24 hours, CVA, renal failure (GFR< 50mmol), pregnancy and hstory of anafilactic shock after tranexamic use.
Intervention groups
Intervention group recieved 1gr tranexamic acid intravenously in 100 ml normal salin0.9% within 10 minutes and 1gr tranexamic acid in 500 ml normal salin0.9% within 8 hours. In control groups same amounts of normal salin 0.9% will be injected.
Main outcome variables
Main outcome: In-hospital mortality, hematom expantion in follow uo brain CT scan, prehematomal edema, functional outcome after 90 days wit Modified Rankin Scale (MRS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220520054927N1
Registration date: 2022-09-08, 1401/06/17
Registration timing: registered_while_recruiting

Last update: 2022-09-08, 1401/06/17
Update count: 0
Registration date
2022-09-08, 1401/06/17
Registrant information
Name
Seyed ali Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 310 8224
Email address
a.alavi.ns@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tranexamic acid administration on non-traumatic Intracerebral hemorrhage in contrast with placebo in Namazi hospital.
Public title
The effect of Tranexamic acid administration on non-traumatic Intracerebral hemorrhage in contrast with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-75 years old Acute non-traumatic intra-paranchimal hemorrhage Less than 12 hours since bleeding
Exclusion criteria:
Multiple intra-paranchimal hemorrhage Contraindication for Anti-phybrinolytic treatment Massive ntra-paranchimal hemorrhage (>70cc) Stem ICH cerebral aneurysm or vascular anomalies Post CVA hemorrhagic formation Cerebral venous thrombosis Anti-thrombolytic therapy Brain tumor or infection
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible patients will be randomized as case and control groups. in the case group, they will receive Tranexamic acid and in the control group, they will receive a placebo. To allocate participants in case and control groups, permuted block randomization will be used. based on the sample size (100 patients), 10 blocks that contain 10 numbers will be created. We use Random allocation software to perform randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants in both groups will be blinded to drug or placebo administration via injection of the same amount with the same physical properties of drug or placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethic committees of school of medicine, Shiraz university of medical sciences.
Street address
Zand street, namazi hospital
City
Shiraz
Province
Fars
Postal code
7193613565
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.SUMS.MED.REC.1400.513

Health conditions studied

1

Description of health condition studied
Intraparanchymal hemorrhage
ICD-10 code
I61.0
ICD-10 code description
Nontraumatic intracerebral hemorrhage in hemisphere, subcortical

Primary outcomes

1

Description
Expansion of intraparanchymal hemorrhage
Timepoint
Before intervention, 1 and 3 days later
Method of measurement
Brain CT scan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After admission in hospital and diagnosis of intra paranchimal hemorrhage with radiologic evaluations, patients will receive Injection of 1gr tranexamic acid intravenously in 100cc normal salin 0.9% within 10 minutes, then 1gr tranexamic acid in 50cc normal salin 0.9% within 8 hours. Also, all patients in intervention group will be treated with necessary routine drugs such as anticonvusive and antihypertension drugs.
Category
Treatment - Drugs

2

Description
Control group: Control group: In this group receive the same anticonvulsive and antihypertension drugs, also same amount of normal salin 0.9% but distilled water will be injected instead of tranexamic acid as a placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mohammad Jamali
Street address
Namazi hospital, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 3647 3882
Email
a.alavi.ns@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ali Alavi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 3647 3882
Email
a.alavi.ns@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz Medical University of Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Jamali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 3647 3882
Email
mohammad.jamali.ns@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Jamali
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7193613565
Phone
+98 71 3647 3882
Email
mohammad.jamali.ns@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Ali Alavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7136473882
Phone
009838724977
Email
a.alavi.ns@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Full text of original article Data file
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for people working in academic institutions and who works in businesses
Under which criteria data/document could be used
Any analytic tests with authors permission is possible.
From where data/document is obtainable
Via Email or telephone numbers
What processes are involved for a request to access data/document
Requaired data will be sent to Email
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