Please select the eligibility criteria that correspond to the clinical trial below.
Title: Retrievable Inferior Vena Cava Filter for Primary Pulmonary Embolism Prophylaxis in At-Risk Trauma Patients: RIPT Feasibility Trial
Brief Summary: The risk of venous thromboembolism (VTE) is very high in trauma patients, secondary to tissue injury, venous status from immobilization, and thrombophilia. As such, early initiation of VTE prophylaxis is essential in this population. The competing risks of life threatening hemorrhage and VTE need to be considered very carefully. Potential approaches to VTE prophylaxis include pharmacologic means, and mechanical devices. For patients unable to receive pharmacologic VTE prophylaxis, retrievable inferior vena cava filters (rIVCFs) may be placed until low molecular weight heparin (LMWH) can be initiated, as per guidelines such as Eastern Association for the Surgery of Trauma

The investigators propose a feasibility study to determine whether or not our center can insert rIVCFs in at-risk trauma patients expeditiously enough to cause a meaningful reduction in the time they are left unprotected to PE.


Options:
A: Inclusion Criteria:

* Must be Age greater than or equal to 18
* Obtain informed written consent.
* Diagnosed with acute pulmonary embolism (PE) (\< 14 days)
* Catheter-directed therapy (CDT) was performed to treat acute PE
B: Criteria: Inclusion Criteria:

* Subject is eligible for catheter directed thrombolysis per the study protocol for submassive PE (CT or echocardiographic RV strain (defined as RV/LV ratio \>1) without persisting hypotension \<90mmHg or drop of systolic blood pressure by at least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \<30 mL/h or mental confusion) and without the need of catecholamine support or cardiopulmonary resuscitation).

Exclusion Criteria:

* pregnancy;
* index PE symptom duration \>14 days;
* high bleeding rsk (any prior intracranial hemorrhage,
* known structural intracranial cerebrovascular disease or neoplasm,
* ischemic stroke within 3 months,
* suspected aortic dissection, active bleeding or bleeding diathesis,
* recent spinal or cranial/brain surgery,
* recent closed-head or facial trauma with bony fracture or brain injury);
* participation in any other investigational drug or device study;
* life expectancy \<90 days;
* inability to comply with study assessments.
C: Inclusion Criteria:

* consecutive age adult trauma patients who are:

  1. Deemed unable to receive medial VTE prophylaxis within 72 hours post injury based on traumatologists' suspicion of increased bleeding risk, peri-spinal cord bleeding risk, or need for multiple surgical interventions.

     AND
  2. have at-least on of the following high risk VTE injuries as per EAST Guidelines:

     1. severe closed head injury (GCS 8 or less upon presentation)
     2. incomplete spinal cord injury with paraplegia or quadriplegia
     3. complex pelvic fracture with associated long bone fracture(s)
     4. multiple long bone fractures

Exclusion Criteria:

1. Patients not expected to survive for at least 72 hours post trauma
2. Patients with known uncorrectable coagulopathy
3. Patients known to be unable to receive a rIVC filter as part of this trial (for anatomical reasons or standard contraindication for device insertion)
4. Known active venous thromboembolic disease
5. Pregnancy
D: Inclusion Criteria:

* Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)
* PE symptom duration less than or equal to (\<=)14 days
* Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
* Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
* Submassive PE (RV diameter-to-LV diameter greater than or equal to \[\>=\] 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

* Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
* Recent (within one month) or active bleeding from a major organ
* Hematocrit less than (\<) 30 percent (%)
* Platelets \< 100 thousand/microliter (mcL)
* International Normalized Ratio (INR) greater than (\>) 3
* Activated partial thromboplastin time (aPTT) \>50 seconds on no anticoagulants
* Major surgery within seven days of screening for study enrollment
* Serum creatinine \>2 milligrams/deciliter (mg/dL)
* Clinician deems high-risk for catastrophic bleeding
* History of heparin-induced thrombocytopenia (HIT)
* Pregnancy
* Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
* Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
* Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
* Evidence of irreversible neurological compromise
* Life expectancy \<30 days
* Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
* Previous enrollment in the SEATTLE study

Answer: C