Blood Coagulability in CopdNCT05380960
Blood Hpercoagublity in Copd
An observational study of Blood Coagulability in Copd, run by Assiut University.
Trial summary
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital" Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulability in Copd
- What is being tested?
- cbc coaglation profile
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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)
Who may be able to join
- 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:
- 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.
- 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
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study on the State of Coagulability in Patients With Chronic Obstructive Disease Admitted to Assiut University Hospital
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital"
Read the 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]
- Conditions
- Blood Coagulability in Copd
- Being tested
- cbc coaglation profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cbc coaglation profileDevice
Also called d dimer crp
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).
| Study group | Role | What they receive |
|---|---|---|
| copd in acute excerbtion | (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. Receives: Device: cbc coaglation profile | |
| (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. Receives: Device: cbc coaglation profile | |
| normal persons | have no diseases Receives: Device: cbc coaglation profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital"
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulability in CopdStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Nashaat Mohamed Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380960
- Sponsor's protocol ID
- hpercoagubiliy in copd
- Status last verified
- May 2022
- First submitted
- 14 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castellana G, Intiglietta P, Dragonieri S, Carratu P, Buonamico P, Peragine M, Capozzolo A, Carone M, Carpagnano GE, Resta O. Incidence of deep venous thrombosis in patients with both Pulmonary Embolism and COPD. Acta Biomed. 2021 Jul 1;92(3):e2021210. doi: 10.23750/abm.v92i3.11258.
PubMed 34212912Jimenez D, Agusti A, Tabernero E, Jara-Palomares L, Hernando A, Ruiz-Artacho P, Perez-Penate G, Rivas-Guerrero A, Rodriguez-Nieto MJ, Ballaz A, Aguero R, Jimenez S, Calle-Rubio M, Lopez-Reyes R, Marcos-Rodriguez P, Barrios D, Rodriguez C, Muriel A, Bertoletti L, Couturaud F, Huisman M, Lobo JL, Yusen RD, Bikdeli B, Monreal M, Otero R; SLICE Trial Group. Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2021 Oct 5;326(13):1277-1285. doi: 10.1001/jama.2021.14846.
PubMed 34609451Couturaud F, Bertoletti L, Pastre J, Roy PM, Le Mao R, Gagnadoux F, Paleiron N, Schmidt J, Sanchez O, De Magalhaes E, Kamara M, Hoffmann C, Bressollette L, Nonent M, Tromeur C, Salaun PY, Barillot S, Gatineau F, Mismetti P, Girard P, Lacut K, Lemarie CA, Meyer G, Leroyer C; PEP Investigators. Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms. JAMA. 2021 Jan 5;325(1):59-68. doi: 10.1001/jama.2020.23567.
PubMed 33399840Lankeit M, Held M. Incidence of venous thromboembolism in COPD: linking inflammation and thrombosis? Eur Respir J. 2016 Feb;47(2):369-73. doi: 10.1183/13993003.01679-2015. No abstract available.
PubMed 26828045
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the State of Coagulability in Patients With Chronic Obstructive Disease Admitted to Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05380960
- Acronym / sponsor ID
- hpercoagubiliy in copd
- Conditions
- Blood Coagulability in Copd
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| copd in acute excerbtion | – | Device: 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). | – | Device: cbc coaglation profileWe plan to include patients admitted at the RICU with bronchial asthma, bronchiectasis, pneumonia, and interstitial lung disease. |
| normal persons | – | Device: cbc coaglation profilehave no diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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)
Key inclusion criteria (5 listed)
- 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 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.
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cbc coaglation profileAlso: d dimer crpThe 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). | Device | (2) The second group (non-COPD lung diseases group)., copd in acute excerbtion, normal persons |
Primary outcome
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital"
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 34212912Castellana G, Intiglietta P, Dragonieri S, Carratu P, Buonamico P, Peragine M, Capozzolo A, Carone M, Carpagnano GE, Resta O. Incidence of deep venous thrombosis in patients with both Pulmonary Embolism and COPD. Acta Biomed. 2021 Jul 1;92(3):e2021210. doi: 10.23750/abm.v92i3.11258.
- Background: PubMed 34609451Jimenez D, Agusti A, Tabernero E, Jara-Palomares L, Hernando A, Ruiz-Artacho P, Perez-Penate G, Rivas-Guerrero A, Rodriguez-Nieto MJ, Ballaz A, Aguero R, Jimenez S, Calle-Rubio M, Lopez-Reyes R, Marcos-Rodriguez P, Barrios D, Rodriguez C, Muriel A, Bertoletti L, Couturaud F, Huisman M, Lobo JL, Yusen RD, Bikdeli B, Monreal M, Otero R; SLICE Trial Group. Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2021 Oct 5;326(13):1277-1285. doi: 10.1001/jama.2021.14846.
- Background: PubMed 33399840Couturaud F, Bertoletti L, Pastre J, Roy PM, Le Mao R, Gagnadoux F, Paleiron N, Schmidt J, Sanchez O, De Magalhaes E, Kamara M, Hoffmann C, Bressollette L, Nonent M, Tromeur C, Salaun PY, Barillot S, Gatineau F, Mismetti P, Girard P, Lacut K, Lemarie CA, Meyer G, Leroyer C; PEP Investigators. Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms. JAMA. 2021 Jan 5;325(1):59-68. doi: 10.1001/jama.2020.23567.
- Background: PubMed 26828045Lankeit M, Held M. Incidence of venous thromboembolism in COPD: linking inflammation and thrombosis? Eur Respir J. 2016 Feb;47(2):369-73. doi: 10.1183/13993003.01679-2015. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulability in Copd, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeinab nashaat, resident doctor (01093269478, zeze15151515@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"The objective of this study is to evaluate the blood coagulability state in patients with COPD admitted at Assiut University Hospital" (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05380960, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.