| CTRI Number |
CTRI/2024/01/061068 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY ANALYSING THE RELATIONSHIP BETWEEN ELEVATED D DIMER VALUE IN TRAUMA PATIENTS , SCHEDULED FOR SURGERY AND OCCURRENCE OF LONGTERM ADVERSE CARDIOVASCULAR EVENTS |
|
Scientific Title of Study
|
A COHORT STUDY ON ELEVATED
D DIMER VALUE AND LONGTERM CARDIOVASCULAR OUTCOME AMONG TRAUMA PATIENTS SCHEDULED FOR SURGERY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joe John Chirayath |
| Designation |
Associate Professor , Department of Anaesthesiology |
| Affiliation |
Amala institute of medical sciences, Thrissur, Kerala |
| Address |
Amala institute of medical sciences, Amalanagar 680555
Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
9526454443 |
| Fax |
|
| Email |
Joechirayath@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anntrisa K Manavath |
| Designation |
Postgraduate student, MD Anaesthesiology, Department of Anaesthesiology |
| Affiliation |
Amala institute of medical sciences, Thrissur |
| Address |
Postgraduate student ,
MD Anaesthesiology,
Department of Anaesthesiology
Amala institute of medical sciences
Thrissur, Kerala 680555
Thrissur
KERALA
680555
India |
| Phone |
9447781405 |
| Fax |
|
| Email |
anntrisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anntrisa K Manavath |
| Designation |
Postgraduate student , MD Anaesthesiology, Department of Anaesthesiology |
| Affiliation |
Amala institute of medical sciences, Thrissur |
| Address |
Postgraduate student,
MD Anaesthesiology
Department of Anaesthesiology
Amala institute of medical sciences
Thrissur, Kerala 680555
Thrissur
KERALA
680555
India |
| Phone |
9447781405 |
| Fax |
|
| Email |
anntrisa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala institute of medical sciences, Thrissur,Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Anntrisa K Manavath |
| Address |
Post graduate student
MD Anaesthesiology
Department of Anaesthesiology
Amala institute of medical sciences, Amalanagar, 680555, Thrissur, Kerala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anntrisa K Manavath |
Department of Anaesthesiology ,Amala institute of medical sciences, Thrissur , 68055 |
Department of Anaesthesiology ,
Trauma cases in ICU and wards
Thrissur
KERALA |
9447781405
anntrisa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amala institute of medical sciences, Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T798||Other early complications of trauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with history of trauma scheduled for elective surgery |
|
| ExclusionCriteria |
| Details |
1)ASA PS 4 and 5
2)Antenatal patients with trauma
3)Patients with history of DVT , pulmonary embolism, myocardial infarction in the past |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major Adverse cardiac events |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Morbidity |
6 months |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By contacting the contact person via email.
- For how long will this data be available start date provided 12-01-2025 and end date provided 12-09-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a cohort study to find out whether an elevated D dimer value , which is usually associated with trauma and surgery making them a procoagulant state , could lead to major adverse cardiovascular events such as DVT, Pulmonary embolism, myocardial infarction, Stroke . Trauma patients without any history of cardiovascular diseases, who are scheduled for elective surgery are selected as the study population. |