Completed

NCT Number: NCT02977013

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.

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Key information

Conditions

Anti-Xa Assay in Pulmonary Embolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Anti-Xa assay

Diagnostic Test

Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism

Primary outcomes

Recurrent pulmonary embolism

Time frame: 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

Time frame: 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
Bleeding

Time frame: 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
Death

Time frame: 4 Weeks

Defined as all deaths occurring within the 4 weeks of the study

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Mohamed Abbas

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Nov 30, 2016
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.