Rivaroxaban Versus Enoxaparin for Prophylaxis of Venous Thromboembolism in Bariatric Surgery

NCT06689241 | Recruiting DMC

• 1 other identifier: 0306920
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Rivaroxaban versus enoxaparin for prophylaxis of venous thromboembolism in morbidly obese patients undergoing bariatric surgery: An open\_label randomized controlled trial

Conditions

Morbid Obesity; Bariatric Surgery Candidate

Keywords

venous thromboembolism; enoxaparin; rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Incidence of thromboembolic events

  deep vein thrombosis, pulmonary thromboembolism, mesenteric vascular occlusion

  month 3 postoperative

Secondary Outcomes (4)

• incidence of postoperative bleeding

  one month postoperative

• incidence of reoperation

  month 3 postoperative

• incidence of readmission

  month 3 postoperative

• patient satisfaction using likert scale

  month 3 postoperative

Study Arms (2)

group E

ACTIVE COMPARATOR

81 patients will receive subcutaneous enoxaparin 40 mg every 24 hours starting 12 hours after bariatric surgery for 14 days.

Drug: Enoxaparin

group R

EXPERIMENTAL

81 patients will receive oral rivaroxaban 10 mg once daily starting 24 hours after bariatric surgery for 14 days.

Drug: rivaroxaban

Interventions

Enoxaparin DRUG

40mg

Also known as: group E

group E

rivaroxaban DRUG

10mg

Also known as: group R

group R

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-60 years, both sexes.
• ASA physical status class I to III.
• BMI 35-50 kg/m²

You may not qualify if:

• Severe cardiac disorder
• chronic renal failure
• liver cirrhosis
• major psychological disorder

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

• Wagner J, Wruck H, Lautenbach A, von Kroge P, Wolter S, Mann O, Izbicki J, Dupree A. Comparison of Anti-factor Xa Levels in Female and Male Patients with Obesity After Enoxaparin Application for Thromboprophylaxis. Obes Surg. 2022 Mar;32(3):861-867. doi: 10.1007/s11695-021-05875-z. Epub 2022 Jan 5.

  PMID: 34988894 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Venous Thromboembolism

Interventions

Enoxaparin; Rivaroxaban

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• sarah m elgamal, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440; sarahelgamal1990@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer anesthesia and intensive care

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)