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

Anti-Xa Assay in Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977013
• Other study ID #: MSAT-5
• Status: Completed
• Phase: N/A
• First received: November 27, 2016
• Last updated: March 31, 2017
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Al Mouwasat Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anti-Xa Assay in Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Anti-Xa assay
Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Mohamed Abbas

References & Publications (1)

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. Epub 2004 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Death	Defined as all deaths occurring within the 4 weeks of the study	4 Weeks