Measurement of blood levels of D-dimer and CRP in brain dead patients and the effect of heparin with therapeutic dose on early renal and hepatic function of these organs in brain dead patients
Improving of kidney and liver transplant organ function in recipients from brain dead patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 1-2 on 73 patients. Computer random table method was used for randomization
Settings and conduct
A double-blind clinical trial on 73 male and female patients with brain death who are candidates for organ donation at Sina Hospital in Tehran. The patients were randomly divided into two groups using a computerized random table method. The study is double-blind. Blinding process: The person who injected the drug does, the analyst, the outcome evaluator and the participant (double-blind) take place.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Brain dead patients aged 10-60 who are candidates for organ donation and have higher than normal CRP and D-dimer. Kidney failure patients undergoing dialysis on the transplant list and liver failure patients on the transplant list.
Exclusion criteria: Exclusion criteria: Patients who are kidney or liver recipients for the second time. Brain death patients with Cr > 2.5mg/dl.
Intervention groups
Intervention group: 5000 units of intravenous heparin are injected every 6 hours from the beginning of the study. Control group: 5000 units of intravenous heparin are injected every 12 hours from the beginning of the study.
Main outcome variables
Measurement of the kidney and liver function organ in kidney and liver recipient patients from brain death patients who received heparin therapy or prophylaxis before organ donation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N16
Registration date:2023-04-17, 1402/01/28
Registration timing:registered_while_recruiting
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Measurement of blood levels of D-dimer and CRP in brain dead patients and the effect of heparin with therapeutic dose on early renal and hepatic function of these organs in brain dead patients
Public title
Heparin thrapy in brain dead patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Brain death patients in the ages of 10 to 60 years
Renal failure patients undergoing dialysis on the transplant list
Liver failure patients on the transplant list
Brain death patients with D-dimer more than 500ng/ml
Brain death patients with CRP greater than 20mg/L
Exclusion criteria:
Brain death patients who have Cr≥2.5 mg/dl.
Renal failure patients who did not have a history of previous successful transplantation
Liver failure patients who did not have a history of previous successful transplantation
Age
From 10 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
73
Randomization (investigator's opinion)
Randomized
Randomization description
For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the intensive care of unit who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is H, it will be transferred to the intervention group, and if it is C, it will be transferred to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients do not know their group. Eligible participants to receive heparin therapy (group H) or prophylactic heparin (group C) are determined according to a computerized randomization program.These drugs are prepared in syringes and the same volume and are identified with the patient's name and hospital registration number, and in the special care department, these drugs are given to the nurse caring for the patient who is blind to the assigned groups for injection.Another investigator, who is blinded to the assigned groups, will evaluate the status of transplant success in kidney and liver recipients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sina Hospita
Street address
Sina Hospital, Imam Khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.064
Health conditions studied
1
Description of health condition studied
Brain dead
ICD-10 code
G96.8
ICD-10 code description
Other specified disorders of central nervous system
2
Description of health condition studied
Thrombophilia
ICD-10 code
D68.69
ICD-10 code description
Other thrombophilia
Primary outcomes
1
Description
Serum urea and creatinine of kidney transplant recipients
Timepoint
At the beginning of the patient's entry into the study and then daily until 7 days after transplantation
Method of measurement
By sending patients' blood samples to the laboratory
2
Description
Measurement of liver enzymes and bilirubin in liver transplant recipients
Timepoint
At the beginning of the patient's entry into the study and then daily until 7 days after transplantation
Method of measurement
By sending patients' blood samples to the laboratory
3
Description
Measurement of D-dimer in brain death patients
Timepoint
Once and 24 hours before organ donation
Method of measurement
By sending patients' blood samples to the laboratory
4
Description
Measurement of CRP in the blood of brain dead patients
Timepoint
Once and 24 hours before organ donation
Method of measurement
By sending patients' blood samples to the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 6 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation
Category
Treatment - Drugs
2
Description
Control group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 12 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammadreza Khajavi
Street address
Sina Hospital,Imam Khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital,Hasan Abad Sq, Imam Khomeni St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital,Hasan Abad Sq,Imam Khomeni St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
KHAGAVIM@TUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Hasan Abad Square, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
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
Not applicable
Title and more details about the data/document
Main study outcome data
When the data will become available and for how long
Six months after the end of the study
To whom data/document is available
University researchers
Under which criteria data/document could be used
Share experiences to increase the knowledge
From where data/document is obtainable
khajavim@tums.ac.ir -Dr.khajavi
What processes are involved for a request to access data/document
The request will be made by email and the answer will be given within two months