Blood Hpercoagublity in Copd

• Conditions: Blood Coagulability in Copd
• Interventions: Device: cbc coaglation profile

• Registration Number: NCT05380960
• Lead Sponsor: Assiut University

Brief Summary

"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital"

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a chronic debilitating lung disease with a high prevalence of approximately 380 million cases worldwide \[1\]. It is currently the third leading cause of death, responsible for approximately 6% of the world's total deaths (approximately 3.3 million annually) \[2\]. In addition to the known devastating respiratory consequences, a large number of studies support the hypothesis that COPD increases the risk for both venous thromboembolism (VTE) and cardiovascular disease (CVD) Although the observed association of COPD with CVD and VTE can be partially explained by comorbidities and shared risk factors, there is strong evidence that COPD increases the risk for cardiovascular morbidity and mortality independently of age, gender, and smoking history \[3,4\]. It is of note that up to 63.5% of patients with COPD die of comorbid circulatory system diseases \[5\].

Increased thrombin formation \[6\] , reflected by elevated thrombin-antithrombin com- plexes \[7\] , tissue factor procoagulant activity \[8\] and activated factor XI \[9\] , increased d-dimers \[10\] , and FI \[11\] , FII and FX \[12\] levels in the serum of COPD patients support the theory that a hypercoagulable state occurs in patients with COPD and might contribute to the incidence of atherothrombotic events and VTE, increasing disease related morbidity and mortality.

Potential pathways illustrating pathogenetic mechanisms of increased risk of CVD and VTE in COPD are imprecise. Evidence illustrates four possible synergistic mechanisms: systemic inflammation \[13\], platelet activation \[14\] , oxidative stress \[15\], and hypoxia, either sustained in severe COPD or intermittent during exercise and sleep \[16,17\]

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-14
• Study First Submitted QC: 2022-05-14
• Last Update Submitted: 2022-05-14
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Study Start: 2022-06-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. The first group (COPD group) in acute exacerbaction: We plan to include COPD patients who will be admitted to the Chest Diseases Department with severe exacerbation requiring admission to the RICU (severe dyspnea that responds inadequately to initial emergency therapy, changes in mental status, persistent or worsening hypoxemia, persistent or worsening respiratory acidosis, the need for ventilatory support, and/or hemodynamic instability.

   The diagnosis of COPD was based on the patient's medical history obtained from the patient himself and/or the family of the patient, consistent physical findings, previous spirometry and/or evidence of hyperinflation on current or previous chest radiograph.

   The participants will be divided into three groups:

2. The second group (non-COPD lung diseases group). We plan to include patients admitted at the RICU with bronchial asthma, bronchiectasis, pneumonia, and interstitial lung disease.

3. The the third group (healthy control group). This group will include volunteers who are apparently healthy in every aspect exculsion ctritria 1. Primary hematological disease. 2. Coagulation disorders. 3. Malignancy anywhere in the body. 4. Hepatic disease. 5. Renal disease. 6. Taking anticoagulant and/or antiplatelet medications

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal persons	cbc coaglation profile	have no diseases
copd in acute excerbtion	cbc coaglation profile	(1) The first group (COPD group) in acute exacerbaction: We plan to include COPD patients who will be admitted to the Chest Diseases Department with severe exacerbation requiring admission to the RICU (severe dyspnea that responds inadequately to initial emergency therapy, changes in mental status, persistent or worsening hypoxemia, persistent or worsening respiratory acidosis, the need for ventilatory support, and/or hemodynamic instability.
(2) The second group (non-COPD lung diseases group).	cbc coaglation profile	We plan to include patients admitted at the RICU with bronchial asthma, bronchiectasis, pneumonia, and interstitial lung disease.

Primary Outcome Measures

Name	Time	Method
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital"	baseline	The Demographic, clinical, and laboratory data for the enrolled subjects will be collected. To assess the coagulability state in the participants, we will measure the levels of certain markers in the blood that are thought to be associated with an increased coagulability. A comparison will be made between the different included groups regarding the level of these markers. These markers included complete blood count (CBC) indices (hematocrit, red cell distribution width, platelets count, mean platelet volume and platelet distribution width), C - reactive protein, d dimer, and blood coagulation tests (prothrombin time, international normalized ratio and partial thromboplastin time).