Optimising care following major surgery to prevent clots: How much intervention is really needed and at what cost?

Not Applicable

Recruiting

• Conditions: Venous thromboembolism; Pulmonary Embolism; Deep vein thrombosis; Diseases of the vasculature and circulation including thelymphatic system; Clotting disorders; Diseases of the vasculature and circulation including the; lymphatic system; Surgery - Other surgery

• Registration Number: ACTRN12622001527752
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-12
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4130

Inclusion Criteria

•Patient undergoing elective major surgery with major surgery defined as any operation deemed by the surgical team to be requiring admission to hospital beyond 24 hours
•>18 years of age
•Moderate or high risk of venous thromboembolism (VTE) based on NSW risk assessment form

Exclusion Criteria

•Are unable to give written informed consent to take part in the study
•are not expected to be ambulant within 24 hours
•Have contraindications to LMWH
•Have contraindications to GCS or IPCDs
•Have had previous heparin-induced thrombocytopenia/thrombosis (HITT)
•are undergoing lower leg surgery (orthopaedics)
•Have active, clinically significant bleeding (Class 2 and above) i.e. volume loss of 15% to over 40% of total blood volume.
•Have documented congenital or acquired bleeding tendency/disorders
•Have had a recent intracranial haemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery
•Have epidural or spinal anaesthesia planned
•Have active peptic ulcer or treatment of same in the last three months
•Have severe liver disease (Liver cirrhosis)
•Have current thrombocytopenia e.g., platelets <70
•Have renal Impairment GFR <30 and or creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participant
•Are pregnant and/or breastfeeding women
•Have evidence of leg ischemia caused by peripheral vascular disease (previously documented or on clinical assessment)
•Have clinical signs of VTE and/or a history of VTE- Pulmonary embolism, Deep vein thrombosis
•Have pre-existing indications for heparins (including LMWH). These are people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks ie Atrial fibrillation, Pulmonary hypertension, Cardiomyopathy, Ischemic stroke, Certain congenital heart disorders, Artificial valve replacement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Symptomatic Venous thromboembolism. This is either deep vein thrombosis (DVT) or Pulmonary Embolism (PE).[Identified during days 30 and 90 post-surgery (primary endpoint) by follow-up phone call and confirmed by USS or imaging.]