Anti-Xa Assay Correlation to the Efficacy and Safety of Enoxaparin in the Treatment of Pulmonary Embolism

Completed

• Conditions: Anti-Xa Assay in Pulmonary Embolism
• Interventions: Diagnostic Test: Anti-Xa assay

• Registration Number: NCT02977013
• Lead Sponsor: Mohamed Sayed Mohamed Abbas

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-27
• Study First Posted: 2016-11-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients in ICU and 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.

Exclusion Criteria

• Patients who underwent thrombolysis, embolectomy or if they are unfit for anticoagulant therapy because of major bleeding or thrombocytopenia (a platelet count below 100,000 per cubic millimeter). Patients were also excluded if they had impaired kidney function with a serum creatinine level above 2 mg/dl or uncontrolled hypertension (blood pressure > 160/100 mmHg).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pulmonary embolism treated with enoxaparin	Anti-Xa assay	Anti-Xa assay correlation to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism

Primary Outcome Measures

Name	Time	Method
Bleeding	4 Weeks	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
Recurrent pulmonary embolism	4 Weeks	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	4 Weeks	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
Death	4 Weeks	Defined as all deaths occurring within the 4 weeks of the study