Monitoring Residual LMWH Activity in Patients of Elective Surgery

Phase 4

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/11/060006
• Lead Sponsor: AIIMS, Bhopal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)To be on prophylactic dose of Inj. Enoxaparin at the time of presentation for elective surgery

2)Must be able to accurately report the timing of their last dose and the administered dosage.

3)Patients must also be between the ages of 18-80 years of age

4) Must be able to give written consent to participate.

Exclusion Criteria

1) Factors known to interfere with aPTT monitoring such as lupus anticoagulant disease, clotting factor deficiencies (factor V, VIII, IX, X, XI, XII and von Willebrand disease), severe liver disease, acquired vitamin K deficiency, antithrombin (AT) III deficiency, elevated levels of clotting factors, pregnancy and increased factor VIII level.

2) Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting medication will be excluded as this could unpredictably affect the results of anti-Xa testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Anti-Xa activity levels at 10hours ,12 hours & 14 hours after prophylactic dose of Enoxaparin. <br/ ><br>2.aPTT values at 10 hours, 12 hours & 14 hours after prophylactic dose of <br/ ><br>Enoxaparin <br/ ><br>Timepoint: 10hours ,12 hours & 14 hours after prophylactic dose of Enoxaparin. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Relationship between anti-Xa/aPTT and patients age <br/ ><br>2.Relationship between anti-Xa/aPTT and patients weight <br/ ><br>3.Relationship between anti-Xa/aPTT levels and patients gender <br/ ><br>4. Relationship between anti-Xa/aPTT levels and patients comorbidities. <br/ ><br>Timepoint: preoperative