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

NCT02977013 | Completed

• 1 other identifier: MSAT-5
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anti-Xa Assay in Pulmonary Embolism

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Anti-Xa assay DIAGNOSTIC_TEST

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

Patients with pulmonary embolism treated with enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mohamed Sayed Mohamed Abbas: lead

Related 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. doi: 10.1161/01.CIR.0000136830.65073.C7. Epub 2004 Jul 12.

  PMID: 15249498 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: November 30, 2016
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03