| CTRI Number |
CTRI/2024/02/063249 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
usefulness of Systemic Immune Inflammation Index in predicting outcomes of patients with brain tumors above cerebellum and brain stem undergoing planned surgical removal under general anesthesia |
|
Scientific Title of Study
|
Prognostic Value of Systemic Immune Inflammation Index on outcomes of patients undergoing elective craniotomy surgeries for supratentorial brain tumors: A prospective analytical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samriddhi Bangari |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anesthesiology and Critical Care AIIMS Rishikesh Virbhadra road Rishikesh
309 Saket Colony ajabpur kalan near rewati nursing home dehradun
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126721035 |
| Fax |
|
| Email |
samriddhibangari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
Aiims Rishikesh |
| Address |
Department of Anesthesiology and Critical Care AIIMS Rishikesh Virbhadra road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
Aiims Rishikesh |
| Address |
Department of Anesthesiology and Critical Care AIIMS Rishikesh Virbhadra road Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Samriddhi Bangari |
AIIMS Rishikesh |
OT 12, Level 6, CTVS/neurosurgery OT Complex
Dehradun
UTTARANCHAL |
08126721035
samriddhibangari@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosis of supratentorial brain tumor by MRI or CT Brain
2 Undergoing elective craniotomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
1 Patient refusal to participate in study or refusal to follow up.
2 Patients with severe anemia (hb less than 7 g per L)
3 Neutropenia( less than 1000 million per L) or active infection( TLC more than 11000 million per L)
4 Active inflammatory, hematological, or autoimmune system disease history.
5 History of Chemotherapy or Radiotherapy or Immunomodulators in past 3 months.
6 Severe conditions involving the cardiac, hepatic or the renal system
7 Previous brain tumor surgery or treatment
8 History of drug abuse or anaphylaxis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess predictive value of preoperative Systemic Immune Inflammation Index for favourable prognosis as Karnofsky Performance Scale morethan or equal to eighty in patients undergoing craniotomy surgeries. |
At three months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of preoperative SII index with duration of ICU and hospital stay |
At discharge |
| Correlation of postoperative SII index with duration of surgery |
At the end of surgery |
| Analysis of values of SII, NLR,PLR and LMR |
Preoperatively and postoperatively at 24hrs and 3rd day |
| Analysis of preoperative SII in subgroups ie. Pediatric vs adults and benign vs malignant |
Preoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/03/2024 |
| 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="0"
Days="0" |
|
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
|
Brain tumors place a heavy burden on the healthcare systems because of their high morbidity and mortality. Tumor genesis and progression are characterized by inflammation. There is a strong correlation between the degree of inflammation and the levels of inflammatory cells in the peripheral blood. Different indices calculated from peripheral blood smear have potential value for prognostic prediction of many tumors. One such novel biomarker is Systemic Immune Inflammation index. Several studies have conducted to investigate the prognostic value of SII index on outcomes of various tumors, however not much has been done regarding brain tumors. The little literature that is available is present as retrospective studies. Hence, this study aims to assess the predictive value of SII index in prognosis of supratentorial brain tumor patients undergoing craniotomy, prospectively. |