Assessing the effect of injecting 5000U of heparin during CPR on return of spontaneous circulation and neurologic outcome of patients.
Design
Seventy patients are going to be recruited in this study. We use block randomization by this manner: Seven blocks of ten series of patients are extracted from WWW.randomization.com.
We give 35 ampuls of heparin to a drug manufacturer and he sends us back 70 vials containing 35 vials labeled as A and 35 vials labeled as B. He will also give the researcher a letter which says which of A or B has heparin and another has placebo. This letter will be read only when data-gathering and statistical analysis in done.
During the study, recruited patients receive vial A or B according to randomized series.
Settings and conduct
The patient, the researcher and also the data analyser are blinded because only after analysis, it will be known which group has heparin and another has placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Be alive at the entrance to emergency department
2- Cardiac arrest occurs in the emergency department
3- The age between 30 to 60 years
Exclusion criteria:
1- Traumatic patients
2- Has history of previous CPR
3- Asystole be as the first rhythm seen during CPR
4- Receive any anticoagulant during last 12 hours
5- Has any contraindication for heparin injection (such as disturbed 6- coagulation studies, life threatening bleeding, suspicion of ICH)
6- Suspicion of pulmonary embolism or myocardial infarction as the cause of death
Intervention groups
The group in which patients receive 5000U of heparin during CPR
Main outcome variables
1- Percentage of return of spontaneous circulation (ROSC).
2- Neurologic status at 72 hours after ROSC; containing GCS (Glasgow coma scale) and CPC (Cerebral Performance Category).
3- Neurologic status seven days after ROSC.
4- Percentage of discharge from hospital at 30 days after ROSC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240527061913N1
Registration date:2024-06-17, 1403/03/28
Registration timing:prospective
Last update:2024-06-17, 1403/03/28
Update count:0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
sadegh ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3774
Email address
ebrahimisd@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of heparin on the outcome of CPR: a clinical trial
Public title
Effect of heparin on cardiopulmonary resuscitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be alive at the entrance to emergency department
Cardiac arrest occurs in the emergency department
The age between 30 to 60 years.
Exclusion criteria:
Traumatic patients
Has history of previous CPR
Asystole be as the first rhythm seen during CPR
Receive any anticoagulant during last 12 hours
Has any contraindication for heparin injection (such as disturbed coagulation studies, life threatening bleeding, suspicion of ICH)
Suspicion of pulmonary embolism or myocardial infarction as the cause of death
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In our study each patient should receive one dose of intravenous heparin or placebo which are labeled as A or B.
The sequence of drugs we are going to inject is determined by Randomization.com in every ten patients as a block, such as: ABAAABABBB
Blinding (investigator's opinion)
Triple blinded
Blinding description
We send 35 heparin ampuls to a drug company and they send us back 70 vials on each there is a label of A or B. A closed envelope is taken by the researcher in which there is a letter that says which label is indicator of heparin and which is indicator of placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Imam Reza hospital educational, research and treatment center- Mashhad
Street address
Bahar Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.MUMS.IRH.REC.1403.024
Health conditions studied
1
Description of health condition studied
Cardiopulmonary resuscitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of contiousnes
Timepoint
72 hours later
Method of measurement
Glasgow Coma scale
Secondary outcomes
1
Description
Return of spontaneous circulation
Timepoint
60 minutes
Method of measurement
Examination of physician
2
Description
Discharge from the hospital
Timepoint
30 days later
Method of measurement
Registries of hospital
Intervention groups
1
Description
Intervention group: The group who receive heparin at the beginning of CPR
Category
Treatment - Drugs
2
Description
Control group: The group who receive placebo at the beginning of CPR.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminejad hospital
Full name of responsible person
sadegh Ebrahimi
Street address
Abureihan
City
Mashhad
Province
Razavi Khorasan
Postal code
9155788869
Phone
+98 51 3273 7011
Fax
+98 51 3272 2322
Email
ebrahimisd@mums.ac.ir
Web page address
https://hasheminejad.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Ayyub tavakkolian
Street address
Ahmadabad street
City
mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
tavakkolianA@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Ebrahimi
Street address
ِDaneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 3007
Fax
Email
presidentoffice@mums.ac.ir
Web page address
https://main.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
3d bell, No 28/2, Beheshti Ave (9), Bahar Blvd, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9174658546
Phone
+98 51 3858 4673
Email
Bbrahimisd@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Ebrahimi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
3d bell, No 28/2, Beheshti Avn 9, Bahar Blvd, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9174658546
Phone
+98 51 3858 4673
Email
ebrahimisd@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
3d bell, No 28/2, Beheshti Ave 9, Bhar Blvd, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9174658546
Phone
+98 51 3858 4673
Email
ebrahimisd@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD