Detailed assessment of risks and benefits of inferior vena cava filters on patients with complicated injuries

Phase 2

Completed

• Conditions: Multiple trauma; Venous thromboembolism; Surgery - Surgical techniques; Blood - Clotting disorders

• Registration Number: ACTRN12614000963628
• Lead Sponsor: Medical Research Foundation, Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Patients will be eligible for the trial (1) if they are considered to have contraindications to pharmacologic thromboprophylaxis within 72 hours of hospital admission by their attending trauma or neurosurgeons AND (2) Injury Severity Score >15.

Exclusion Criteria

1. Severe head or systemic injury where death within 48 to 72 hours is expected.
2. Attending clinicians judge that patients are at low-risk of bleeding and can receive pharmacologic thromboprophylaxis within 3 days after major trauma.
3. Patients who have CT evidence of pulmonary embolism on admission to the hospital after trauma.
4. Patients who have been treated with full systemic anticoagulation by warfarin, UFH or LMWH for a pre-existing medical disease (e.g. patients with chronic atrial fibrillation requiring systemic anticoagulation) until admission due to trauma.
5. Pregnant patients.

Specific contraindications to heparin or other form of pharmacologic thromboprophylaxis are listed below.
1.Intracerebral haematoma or contusions
2.Active bleeding on admission requiring more than 6 units of blood transfusion within the first 24 hours of admission after the injury
3.Spinal cord injury resulting in neurological deficits or spinal cord haematoma is demonstrated in the MRI scan of the spine
4.Complex pelvic fractures resulting in significant retroperitoneal haematoma
5.Complex visceral organ injuries (e.g. splenic and liver lacerations) resulting in high risk of intraperitoneal bleeding
6. Others, please specify

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic pulmonary embolism confirmed by CT pulmonary angiography[Day 90 post randomisation];Death -all causes[Day 90 post randomisation]