Effect of prothrombin Concentrate complex on reverse of bleeding due to Rivaroxaban in critically ill patients admitted to intensive care unit
Design
Clinical trial with intervention and control groups, with parallel groups, Double-blind, randomized trial
Settings and conduct
All patients in Neurology, General Imam Reza and orthopedic shohada Hospital
Participants/Inclusion and exclusion criteria
criteria for entering the study includes rivaroxaban use and ages over of 18 years. Exclusion criteria include: Sensitivity of octaplex, patient dissatisfaction ,History of receiving antiplatelet drugs, NSAIDs, oagulation disorders associated with chronic liver disease, IgA deficiency, Ambulatory history,Thrombotic disorders
Intervention groups
Control group: Patients with bleeding in the use of rivaroxaban Which have been treated with FFP.
Study Group: Patients with bleeding in the use of rivaroxaban Which have been treated withPCC
Main outcome variables
blood loss volume and the number of units transfused and blood products
General information
Reason for update
Acronym
PCC
IRCT registration information
IRCT registration number:IRCT20091012002582N20
Registration date:2018-08-19, 1397/05/28
Registration timing:registered_while_recruiting
Last update:2018-08-19, 1397/05/28
Update count:0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prothrombin Concentrate complex on reverse of bleeding due to Rivaroxaban in critically ill patients admitted to intensive care unit
Public title
Effect of prothrombin Concentrate complex on reverse of bleeding due to Rivaroxaban
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who admitted in ICU with major bleeding and Life threatening related to Rivaroxaban
Exclusion criteria:
Unwillingness of the patient
Allergic to PCC
History of receiving antiplatelet drugs&NSAIDs
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
no case
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Tabriz University of Medical Sciences, Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-04-13, 1397/01/24
Ethics committee reference number
IR.TBZMED.REC.1397.124
Health conditions studied
1
Description of health condition studied
Abnormal finding of blood chemistry, major bleeding
ICD-10 code
R79.9 Abno
ICD-10 code description
Abnormal finding of blood chemistry, major bleeding due to coagulopathy
Primary outcomes
1
Description
he amount of bleeding in rivaroxaban use
Timepoint
duration of ICU stay
Method of measurement
blood loss volume and hemodynamic changes
Secondary outcomes
1
Description
the number of units transfused and blood products
Timepoint
From the bleeding time to the stop bleeding
Method of measurement
Measure the number of units transfused and blood products
Intervention groups
1
Description
The intervention group will treat bleeding with P.C.C at 45-50 IU / Kg
Category
Treatment - Other
2
Description
Control group:hemorrhage treatment will consist of 15-10 cc FFP per kilogram of body weight along with crystalloid resuscitation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU, Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
paria_sedaghi@yahoo.com
2
Recruitment center
Name of recruitment center
Shohada hospital ICUا
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada hospital, El-goli street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3389 3336
Fax
+98 41 3389 3337
Email
paria_sedaghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Central Building No. 2, Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU,Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3332 8009
Email
ata.mahmoodpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
ICU director, Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4324
Email
amahmoodpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Paria sedagh
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 0413347054
Email
paria_sedaghi@yahoo.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