Clinical trial NCT05569681: Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients
Official title: Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbid Obesity
Keywords: LMWH
Thromboprophylaxis
Non-orthopedic surgeries
Gynecological surgeries
General surgeries
Bariatric surgeries
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Postsurgical morbidly obese patients will be randomized to receive 2 different doses of Bemiparin
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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 criteria: Inclusion Criteria:

1. Participants required surgical intervention in: general surgery, 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

Primary outcomes:
measure: Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Side effects of both Bemiparin doses
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical university
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: SHAHLA ALALAF
role: PRINCIPAL_INVESTIGATOR
affiliation: Kurdistan Higher Counsel of Medical Specialties
name: Ariana Jawad
role: STUDY_CHAIR
affiliation: Hawler Medial University
name: Abdulkader Alany
role: STUDY_DIRECTOR
affiliation: Hawler Medical University
name: Ali Al-Dabbagh
role: STUDY_CHAIR
References: