An observational study in Anti-Xa Assay in Pulmonary Embolism, sponsored by Mohamed Sayed Mohamed Abbas. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Mohamed Sayed Mohamed Abbas · Observational
The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism.
This prospective randomized trial was conducted on 42 patients 18 years of age or older in ICU diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal filling defect in CT pulmonary angiography and treated with subcutaneous enoxaparin 1 mg/kg/12 hours. The study was conducted from August 2013 to September 2016.
All the patients were examined daily over a period of 4 weeks for symptoms and signs of recurrent pulmonary embolism (recurrent pulmonary embolism was diagnosed if the repeat CT angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram), Platelet count (patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia), bleeding (defined as major overt bleeding requiring blood transfusion > 2 units or marked hemoglobin drop > 2 gm/dl or if the bleeding was intracranial or retroperitoneal) and death (defined as all deaths occurring within the 4 weeks of the study) , Then the results were correlated to anti-Xa assay.
738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.
This study's enrollment of 42 is below the median of 383 across 323 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Mohamed Sayed Mohamed Abbas is the lead sponsor of 4 studies on the registry; none are open to participants now.
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The study was conducted on 42 patients in ICU diagnosed to have pulmonary embolism by CT pulmonary angiography and treated by subcutaneous enoxaparin 1 mg/kg every 12 hours. Anticoagulant therapy was followed by anti-Xa assay done 4 hours after the third dose of subcutaneous enoxaparin and the results were correlated to the clinical outcome of the patients as regards complications (recurrent pulmonary embolism, bleeding, low platelet count and death).
Exclusion Criteria:
Anti-Xa assay correlation to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism
Diagnostic Test: Anti-Xa assay
Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism
Recurrent pulmonary embolism
Recurrent pulmonary embolism was diagnosed if the repeat CT angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram.
Time frame: 4 Weeks
Platelet count
Patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia
Time frame: 4 Weeks
Bleeding
Defined as major overt bleeding requiring blood transfusion \> 2 units or marked hemoglobin drop \> 2 gm/dl or if the bleeding was intracranial or retroperitoneal
Time frame: 4 Weeks
Death
Defined as all deaths occurring within the 4 weeks of the study
Time frame: 4 Weeks
No study locations are listed for this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Mohamed Sayed Mohamed Abbas