- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07656311
Mean Platelet Volume (MPV) as an Early Predictor of Mortality in Intensive Care Patients With Cancer (MPV-CICU)
연구 개요
상세 설명
This retrospective, observational, single-center study will evaluate the predictive value of initial Mean Platelet Volume (MPV) and other hemogram parameters (such as Red Cell Distribution Width [RDW] and platelet count) on intensive care and hospital mortality. The primary objective is to investigate the correlation between these routinely measured, cost-effective biomarkers and survival outcomes in oncological critical care patients. The study hypotheses are structured as follows:
- H0: There is no significant relationship between the admission MPV value and intensive care or hospital mortality in intensive care patients with cancer.
- H1: There is a significant relationship between the admission MPV value and intensive care or hospital mortality in intensive care patients with cancer. Data regarding demographics (age, sex), clinical diagnoses, comorbidities, length of stay, APACHE II, SOFA scores, and laboratory parameters (CRP, procalcitonin) will be extracted from hospital electronic database records. All patient data will be anonymized before statistical analysis.
Note on Study Design: This study is designed as a retrospective cohort study. Due to system registry constraints in the protocol module, the time perspective has been specified as 'Other' (Retrospective Cohort).
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Ankara, 터키 (Türkiye)
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients aged 18 years and older.
- Patients with a pathologically or clinically confirmed diagnosis of cancer (solid or hematological malignancies).
- Patients who were admitted to the Anesthesia Intensive Care Unit (ICU) between 2020 and 2025.
- Patients with an ICU length of stay longer than 24 hours.
- Patients with complete medical records, including baseline complete blood count (CBC) and Mean Platelet Volume (MPV) measured at the time of ICU admission.
Exclusion Criteria:
- Patients under the age of 18.
- Patients who stayed in the intensive care unit for less than 24 hours.
- Patients with missing or incomplete medical charts, laboratory data, or survival status records.
- Patients who were readmitted to the ICU during the same hospital stay (only the first admission will be evaluated).
- Patients who received massive blood or platelet transfusions immediately prior to the baseline laboratory measurement, which could artificially alter platelet parameters.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Oncological ICU Patients
Adult patients (aged 18 and older) with a confirmed cancer diagnosis who were admitted to the anesthesia intensive care unit for longer than 24 hours between the years 2020 and 2025
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Intensive Care Unit (ICU) Mortality
기간: From the date of ICU admission up to ICU discharge, assessed up to 30 days.
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The percentage of oncological patients who died during their stay in the anesthesia intensive care unit.
This will be calculated based on the electronic health records and patient files.
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From the date of ICU admission up to ICU discharge, assessed up to 30 days.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hospital Mortality
기간: From the date of hospital admission up to hospital discharge, assessed up to 60 days.
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The percentage of oncological patients who died during their overall hospital stay (including post-ICU ward follow-up).
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From the date of hospital admission up to hospital discharge, assessed up to 60 days.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-05/106
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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