Randomised clinical trial to assess the feasibility for a larger study comparing the use of three Veno-Thrombo-Embolic prophylaxis treatments in patients undergoing major abdominal surgery.

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Surgery - Other surgery

• Registration Number: ACTRN12619000481178
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Study Completion: 2019-08-26
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

All patients 40 years and over undergoing elective major abdominal surgery with an anticipated length of stay greater than 24 hours and able to attend a 30-day follow-up bilateral lower leg venous ultrasound.

Exclusion Criteria

Patients from the above group will be excluded if they have:
•Unable to give written informed consent to take part in the study,
•Active, clinically significant bleeding
•Documented congenital or acquired bleeding tendency/disorders
•Recent intracranial hemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery
•Patients where epidural or spinal anesthesia is planned and undertaken.
•Known cerebral metastasis
•Participants in whom haemostasis had not been established 6 hours after surgical closure
•Current thrombocytopenia eg platelets <70
•Renal Impairment GFR <30 and or Creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participants
•Pregnant and breastfeeding women
•Participant with evidence of leg ischemia caused by peripheral vascular disease, unable to wear IPCD and graduated compression stockings.
•Participants life expectancy < 6 months,
•Clinical sign of VTE and/or history of recent VTE
•Participants who have pre-existing indication for heparins (including LMWH)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
How many participants out of the 30 can we get to the 30 day Ultrasound Scan[30 day Ultrasound Scan follow-up ]

Secondary Outcome Measures

Name	Time	Method
Review of hospital medical record for admission with diagnosis of PE or VTE[up to day 30]