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

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.

Study Overview

• Status: Completed
• Conditions: Anti-Xa Assay in Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: Anti-Xa assay

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 Type: Observational
• Enrollment (Actual): 42

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with pulmonary embolism treated with enoxaparin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	4 Weeks
Death	Defined as all deaths occurring within the 4 weeks of the study	4 Weeks

Collaborators and Investigators

• Sponsor: Mohamed Sayed Mohamed Abbas

Publications and helpful links

General Publications

• Montalescot G, Collet JP, Tanguy ML, Ankri A, Payot L, Dumaine R, Choussat R, Beygui F, Gallois V, Thomas D. Anti-Xa activity relates to survival and efficacy in unselected acute coronary syndrome patients treated with enoxaparin. Circulation. 2004 Jul 27;110(4):392-8. doi: 10.1161/01.CIR.0000136830.65073.C7. Epub 2004 Jul 12.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: November 27, 2016
• First Posted (ESTIMATE): November 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Dalteparin
• Other Study ID Numbers: MSAT-5