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Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients

Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients

Recruiting
18-90 years
All
Phase N/A

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Overview

Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery.

Description

Venous thromboembolism (VTE) is serious and preventable in patients who have undergone recent surgery . Most surgical patients are required to receive VTE prophylaxis, usually pharmacologic prophylaxis. Notwithstanding, rates of appropriate perioperative thromboprophylaxis remain tenaciously low, although the expansion of quality-improvement efforts has led to widespread hospital implementation of prophylaxis strategies.

Obesity, including morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens (unfractionated heparins, low-molecular-weight heparins, and factor Xa inhibitors) may not provide optimal VTE prophylaxis in these patients especially after surgery. Cumulative evidence and works of the literature suggest that anticoagulant dose adjustments in morbidly obese patients may reduce VTE risk. With the increasing rate of morbid obesity, more high-quality clinical trials are needed to prevent VTE in morbidly obese surgical patients providing effective, safe, prevention strategies

Eligibility

Inclusion Criteria:

  1. Participants required surgical intervention in: general surgery, orthopedic, neurosurgery, gynecology, bariatric surgery
  2. Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
  3. Participant is willing and able to give informed consent for participation in the study.
  4. BMI ≥40kg/m2

Exclusion Criteria:

  1. Having any contraindication to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline platelet count <75 × 108/μl, severe renal disease (glomerular filtration rate <30 ml/minute), severe liver disease, or uncontrolled hypertension (>200/120 mmHg)
  2. Known hypersensitivity to unfractionated or LMWHs
  3. On oral or parenteral anticoagulants within 5 days before surgery
  4. Severe arterial hypertension
  5. Unable to comply with the study treatment and/or follow-up
  6. Receiving prohibited medications
  7. Pregnancy or lactation mother

Study details
    Morbid Obesity

NCT05569681

Hawler Medical University

20 February 2024

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