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evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.
The following will be done for enrolled patients:
Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.
Clinical examination Vital data Local chest examination
Measurement of oxygen saturation using pulse oximeter
Laboratory investigations:
Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile
Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed)
Sepsis-induced coagulopathy score (SIC score)
Sequential organ failure score (SOFA score)
Patients will receive treatment according to the hospital guidelines for different disease stratification severity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic dose low-molecular-weight heparin (LMWH) | Active Comparator | Therapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours |
|
| D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy | Experimental | from admission until the end of hospital stay. Patients will be stratified according to their body weight and D-dimer level and receive LMWH D-Dimer level Body Weight LMWH dose <1 mg/dl <100kg Enoxaparin 40mg OD 100-150kg Enoxaparin 40mg BD >150kg Enoxaparin 60mg BD 1-3 mg/ dl <100kg Enoxaparin 40mg BD 100-150kg Enoxaparin 80mg BD >150kg Enoxaparin 120mg BD >3 mg/ dl Enoxaparin 80mg BD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-molecular-weight heparin | Drug | low-molecular-weight heparin administered via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| mortality | All cause mortality | Until patient is discharged or up to 4 weeks whichever comes first |
| occurrence of venous and/or arterial thrombosis | clinical signs supported by radiological evidence of arterial thrombosis or venous thromboembolism (e.g. venous or arterial duplex and CT scan of the chest with pulmonary angiography) | Until patient is discharged or up to 4 weeks whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of Sepsis-induced coagulopathy | calculation of sepsis induced coagulopathy (SIC) score | Until patient is discharged or up to 4 weeks whichever comes first |
| Occurrence of adult respiratory distress syndrome (ARDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashraf Madkour | Contact | +20 100 177 0703 | asfrah_madkour@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ashraf Madkour | Ain Shams University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Recruiting | Cairo | Non-US | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
Calculation of partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/ FIO2) ratio
| Until patient is discharged or up to 4 weeks whichever comes first |
| Occurrence of sepsis | Calculation of sequential organ failure (SOFA) score | Until patient is discharged or up to 4 weeks whichever comes first |
| ICU admission and need for mechanical ventilation | occurrence of respiratory failure detected by arterial blood gases analysis | Until patient is discharged or up to 4 weeks whichever comes first |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |