| CTRI Number |
CTRI/2019/03/017946 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
05/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of abnormal coagulation and its correlation with iv fluids, blood components transfusion in orthopedic trauma patients |
|
Scientific Title of Study
|
Incidence of perioperative coagulopathy and its correlation with intravenous fluids, blood components transfusion and survival prognosis in orthopedic trauma patients: a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyam Charan Meena |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087003375 |
| Fax |
|
| Email |
drshyam.pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankur Gupta |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087311757 |
| Fax |
|
| Email |
ankurgupta9k7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankur Gupta |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087311757 |
| Fax |
|
| Email |
ankurgupta9k7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Anaesthesia, PGIMER,
CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shyam Charan Meena |
PGIMER, Chandigarh |
Depatment of Anaesthesia & Intensive Care level 4, block a , Nehru hospital
Chandigarh
CHANDIGARH |
7087003375
drshyam.pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years to 65 years having orthopaedic trauma
2. Either sex
3. ASA -I, II and III |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18 years and more than 65 years
3. ASA- IV or more
4. Patients with existing head injury
5. Patients with existing vascular injury
6. Patients who is taking anticoagulant and/or antiplatelet drugs
7. Patients with unstable haemodynamics requiring vasopressor or inotropic
supports
8. Patients with sepsis
9. Patients with chronic liver diseases
10. Patients with known hypercoagulable status
11. Patients with gravid uterus |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the incidence of inadvertent perioperative coagulopathy in orthopaedic trauma patients.
|
Perioperative period, 72 hours postoperative and 30 days postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of coagulopathy with surgery duration, surgical blood loss, IV fluid and blood components transfusion. |
Perioperative period |
| Relationship between coagulopathy and survival rate |
72 hours postoperative and 30 days postoperative. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/03/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Its a prospective observational study to evaluate the incidence of perioperative coagulopathy and its correlation with intravenous fluids, blood components transfusion and survival prognosis in orthopaedic trauma patients in a tertiary care hospital. |