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临床试验/CTRI/2024/02/063249
CTRI/2024/02/063249尚未招募不适用

Prognostic Value of Systemic Immune Inflammation Index on outcomes of patients undergoing elective craniotomy surgeries for supratentorial brain tumors: A prospective analytical study

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Diagnosis of supratentorial brain tumor by MRI or CT Brain 2 Undergoing elective craniotomy under general anesthesia.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: At three months postoperatively

次要结局

  • 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)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Samriddhi Bangari

AIIMS Rishikesh

研究点 (1)

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