| CTRI Number |
CTRI/2023/10/058904 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Perioperative coagulation abnormalities in patients undergoing HIPEC surgery |
|
Scientific Title of Study
|
Perioperative coagulopathy in patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy |
| 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 Joona P |
| Designation |
Assistant professor |
| Affiliation |
Malabar cancer centre |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Kodiyeri, Kannur
Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joona P |
| Designation |
Assistant professor |
| Affiliation |
Malabar cancer centre |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Kodiyeri, Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joona P |
| Designation |
Assistant professor |
| Affiliation |
Malabar cancer centre |
| Address |
Department of oncoanaesthesiology, Malabar cancer centre, Moozhikkara P.O, Kodiyeri, Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malabar cancer centre |
| Address |
Moozhikkara P.O, Kodiyeri, Thalassery, Kannur, Kerala,670103 |
| 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 |
| Dr Joona P |
Malabar cancer centre |
moozhikkara p.o, kodiyeri, thalassery, kannur, 670103
Kannur
KERALA |
9496651604
drjoonap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, malabar cancer centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing CRS and HIPEC
patients >18 years and <80 years |
|
| ExclusionCriteria |
| Details |
patients undergoing CRS not proceeding for HIPEC |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of perioperative coagulopathy |
preoperative and first five postoperative days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the factors affecting perioperative coagulopathy & to find out the incidence of postoperative thromboembolic complications |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
29/10/2023 |
| 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="0"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Aim of my study is to find out the incidence of perioperative coagulopathy in patients undergoing CRS with HIPEC , to find the factors contributing to it and also to find out the incidence of thromboembolic complications in the postoperative period.
|