跳至主要内容
临床试验/CTRI/2012/12/003271
CTRI/2012/12/003271已完成不适用

SPLENOMEGALY AND THROMBOCYTOPENIA - IN CORRELATION WITH THE TYPE AND SEVERITY IN MALARIA

DEEPAK CL1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
1.To find whether thrombocytopenia can be used as an early indicator of severity in malaria.

研究概览

简要总结

Malaria is a common communicable disease and is a majorpublic health problem in India, resulting in high morbidity and mortality.Splenomegaly and thrombocytopenia are common findings in malaria.Thrombocytopenia is present in 80% of the patients with malaria and somestudies show that thrombocytopenia in malaria closely correlates with thedegree of parasitemia. However, thrombocytopenia is not included in the WHOcriteria for severe malaria. This study aims to find whether thrombocytopeniacan be an indicator of severe malaria as it is a hematological parameter thatis present even before other features of severe malaria set in. It also aims tofind the association between degree of thrombocytopenia and splenomegaly inmalaria.

Severe malaria is defined accordingto the WHO guidelines. The presence of one or more of the following clinical orlaboratory features classifies the adult patient as suffering from severemalaria. Clinical features like a) impaired consciousness or unrousable coma,b) prostration (generalized weakness so that the patient is unable to walk orsit up without assistance), c) multiple convulsions (>2 episodes in 24hours),d) deep breathing, respiratory distress (acidotic breathing), e) circulatorycollapse or shock (systolic BP <70mmHg), f) clinical jaundice plus evidenceof other vital organ dysfunction, g) hemoglobinuria, h) abnormal spontaneousbleeding, i) pulmonary edema (radiological). Laboratory findings like a)hypoglycemia (blood glucose <40mg/dl), b) metabolic acidosis (plasmabicarbonate <15mmol/l), c) normocytic anemia (Hb <5g/dl, packed cellvolume <15%), d) hemoglobinuria, e) hyperlactataemia (lactate >5mmol/l),f) renal impairment (serum creatinine >3mg/dl), g) hyperparasitemia(2%/100,000/μl in low intensity transmission areas or >5% or 250,000/μl inhigh intensity transmission areas).

Thrombocytopenia by definition isan abnormally low amount of platelets, less than 1,50,000 per microliter ofblood.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 18-60 years admitted with smear positive for falciparum/vivax malaria in Father Muller Medical College Hospital will be included in the study.

排除标准

  • •Patients with a clinical features and/or diagnosis of associated dengue fever, leptospirosis and typhoid fever.
  • •Patients with immunocompromised status or receiving immunosuppressive treatment.
  • •Chronic liver disease.
  • •Pregnant women.

结局指标

主要结局

1.To find whether thrombocytopenia can be used as an early indicator of severity in malaria.

时间窗: Single time point at the end of the study

2.To find the association between degree of thrombocytopenia and splenomegaly in malaria.

时间窗: Single time point at the end of the study

3.To correlate thrombocytopenia and splenomegaly with type and severity in malaria.

时间窗: Single time point at the end of the study

次要结局

未报告次要终点

研究者

发起方
DEEPAK CL
申办方类型
Other [DEEPAK CL]

研究点 (1)

Loading locations...

相似试验