Pulmonary Embolism Clinical Trial
Official title:
Assessment of the Association Between Thrombus Localization and Accompaying Disorders ,Rısk Factors, D-Dimer and Red Cells Distribution Witdh In Pulmonary Embolisim
ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to determine the association between thrombus localization and risk factors, accompanying disorders, D-dimer and the red blood cell distribution width (RDW) in patients with pulmonary embolism.
Background Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic
thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to
determine the association between thrombus localization and risk factors, accompanying
disorders, D-dimer and the red blood cell distribution width (RDW) in patients with
pulmonary embolism.
Material/Methods In 148 patients diagnosed with pulmonary embolism, the presence and
anatomical localization of the thrombus were assessed with Computed tomographic pulmonary
angiography. The accompanying disorders, risk factors, serum D-dimer, and the RDW in the
patients were retrospectively evaluated.
Background Pulmonary embolism (PE) is a serious cardiopulmonary disorder caused by partial
or complete obstruction of the pulmonary arterial bed by a thrombus formed in systemic
veins. Pulmonary embolism is thought to be a result of the interaction between the patient
and risk factors 1-3. In case of suspected PE, clinical, laboratory, and radiological
findings should be carefully studied. Since the clinical findings in PE are non-specific,
objective diagnostic tests are required for the diagnosis 4. Computed tomographic pulmonary
angiography (CTPA) is increasingly being used as the first investigation for suspected PE.
The extent of PE is commonly expressed by indicating the anatomical level of the most
proximal vessel affected by a thrombus 5. For the definite diagnosis of suspected PE, one of
the tests to be used is the determination of the D-dimer level. Plasma D-dimer measurement
provides information about fibrin-degradation fragment following fibrinolysis. D-dimer
assays have low specificity, but high sensitivity and negative predictive value in most
patients with suspected thromboembolism 6. The red cell distribution width (RDW) is a
quantitative indicator of the size variability of red blood cells. This parameter can be
easily obtained from a full blood count and is accepted as an indicator of ineffective red
cell production 7. Some studies have suggested that RDW may be associated with
cardiovascular and pulmonary diseases including PE 8-13.
The purpose of this study was to determine the association between thrombus localization and
risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in
patients with pulmonary embolism.
Material and Methods Study design The data confirmed on 148 patients having PE by CTPA in
the Clinic of Chest Diseases, Medical School, Yüzüncü Yıl University, Van, Turkey, in the
period between January 2012 and August 2014 were retrospectively studied. The patients'
accompanying disorders, risk factors, and the dosing of D-dimer performed on the same day of
the CTPA and RDW levels were noted. The patients who had a story of hospitalising for
reasons other than surgery such as Pneumonia, apses, brucella, encephalitis and the
bedridden patients such as hemiplegia and long-term immobilised patients (>72 hours) after
surgery were listed in the immobilisation group.
Patients receiving the diagnosis of PE with no CTPA performed and 6 patients whose
haemoglobin values were below 11 were not included in this study.
Computed tomographic pulmonary angiography A thoracic CT scan was performed using a
16-detector multi-sectional CT scanner (Somatom Emotion 16-slice; CT2012E-Siemens AG, Berlin
and München-Germany) by injecting contrast agents intravenously, while the patient held her
breath. Contrast-enhanced images were obtained 50-70 sec after IV administration of 120 ml
of ionic iodinated contrast agent, iodiksanol (Visipaque 320 mg/100 ml, Opakim) using a
power injector at a rate of 2 ml/sec.
The parameters used were 120-130 (Kv), 80-120 (Ef-Mass), 0.6 sec (rotation time), 16 mm×1.2
mm (acquisition), 1.2 mm (slice collimation), 5.0-3.0 (slice width), 0.80 (pitch factor),
5.0 mm (increment), and 512×512 (matrix).
D-dimer test The patients' blood specimens were evaluated in the Clinical Hematology
Laboratory. The D-dimer levels were measured with a latex-enhanced photometric method ( Sta
compact, Dade Behring, Marburg, Germany) using D-dimer kits.
Red blood cell distribution width (RDW) The red cell distribution width (RDW) was determined
in whole blood specimens. The hematological analysis was performed with a Coulter LH 750
Complete Blood Count device (Beckman Coulter, Fullerton, California, USA).
The study was planned according to the Declaration of Helsinki and rules of the Hospital
Ethics Committee.
Statistical analysis Descriptive statistics were presented with frequency and percent for
categorical data, and with mean and standard deviation for numerical data. Comparisons
between 2 independent groups were conducted with Mann-Whitney U test, and Chi-Square test
for non-normally distributed numerical, and categorical variables, respectively. Pairwise
Pearson correlation was executed to estimate linear relationship between characteristics.
Receiver operating characteristic (ROC) curve analysis was utilized to determine the optimum
cutoff level of the association of RDW with MPA. All statistical calculations were performed
using SAS version 9.3 (SAS, 2014). The results were considered statistically significant
when the p value was <0.05.
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Observational Model: Case Control, Time Perspective: Prospective
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