Evidence Table 2. Study Characteristics for KQ1

Evidence Table 2. Study characteristics for KQ1

Author, Year / Study design / Study site – study locations / Recruitment date (start date – end date) / Planned length of follow-up / Method of surveillance for VTE / Funding source / Inclusion criteria / Exclusion criteria
IVCF versus IVCF
Karmy-Jones R, 2007 17 / Cohort-retro / Multiple center- N. America / 2005-2005 / NR / 6 of the 21 centers had formal protocols to screen for DVT with lower extremity duplex ultrasound in high risk patients / NR / R-IVCF or P-IVCF / NR
Keller IS., 200718 / Cohort-retro / Single center-Europe / 1996-2005 / NR / All patients with optional IVC filters used as permanent filters were followed-up once between Dec 2005 & June 2006 by means of clinical examination, venous duplex US from the popliteal vein to the IVC, and plain radiography of abdomen / NR / Filter / NR
O’Keffe, T., 2011 30 / Cohort-retro / Single center-
N. America / 2006-2006 / NR / No / NR / Age: 13<x<89
BMI
Type of trauma: TBI or spinal cord injury, complex pelvic fractures with associated long bone fracture, multiple long bone fractures ICU
Filter
Contraindication to heparin anticipated to exceed 72 hours / NR
Rosenthal D., 200743 / Cohort-retro / Single center-N. America / 2003-2006 / NR / Venous color flow duplex / NR / Male
Female
Multiple trauma patients with relative or absolute contraindications to low dose heparin therapy or barriers to prevent sequential compression devices
ICU
Filter / NR
Rosenthal D., 200942 / Cohort-retro / Single center-N. America / 2004-2008 / NR / No / NR / Filter: Retrievable Gunther Tulip or Celect IVC catheter / NR
Smoot RL, 2010 52 / Cohort-retro / Single center-N. America / 2001-2005 / NR / During the study years, no specific venous thromboembolism (VTE) surveillance protocols were in effect at our institution. Specifically, duplex ultrasound evaluation of extremities was not used for screening of patients but was only obtained when there was clinical suspicion for the presence of a DVT. / NR / Filter / NR
IVCF Versus Control
Gorman PH, 200911 / Cohort-retro / Single center-N. America / 2002-2003 / NR / No / NR / Length of stay at facility > 7 days
Acute spinal cord injury between C3 and L3 / NR
Gosin JS, 199712 / Cohort-pros / Single center-N. America / 1994-1996 / NR / PE documented by ventilation perfusion, Angiogram or autopsy / NR / Age: 17 ≤
Length of stay-ICU: ≥48 hours
Must meet one or more of the high-risk injury criteria: severe closed head injuries (abbreviated injury score of 4 or 5), complex pelvic fractures (disruption of the pelvic ring), spinal cord injuries, or lower-extremity injuries concomitant with significant injury to another body system *injury severity score >15
ICU / NR
Khansarinia S, 199519 / Prospective cohort with historical controls / Single center-N. America / 1992-1994 / All Patients Monitored Until Discharge And If Readmitted To Hospital For Any Reason / Evaluation by B-mode ultrasonography, V/Q scanning, or pulmonary arteriography to document presence or absence of PE. Weekly or twice-weekly lower extremity ultrasonograms obtained before any delayed PGF insertions and on all patients with ICU status greater than 3 days. / NR / ISS: >9
Trauma Center: admitted to level I trauma center
Expected to survive longer than 48 hrs
Must meet one of the following: severe head injury with prolonged ventilator dependence, severe head injury with multiple lower extremity fractures, spinal cord injury with or without paralysis, major abdominal or pelvic penetrating venous injury, or pelvic fracture with lower extremity fractures / NR
Rajasekhar A, 2011 34 / RCT / Single center-N. America / 2008-2010 / 6 Months Post Discharge / CUS for DVT, spiral CT for PE / Industry / Age: >18 years
BMI: >35 kg/m2
Immobility: ≥ 7 days
Type of trauma: spinal cord injury with paralysis, multiple complex pelvic fractures, bilateral LE bone fracture except fibula, pelvic + one or more LE bone fracture excluding fibula
Trauma Center: <96 hours
Expected admission: ≥ 1 week / Pregnancy
Filter: previous placement, contraindications
Terminally ill or anticipated survival <24 hours
Rodriguez JL, 199636 / Cohort-retro / Single center-N. America / 1991-1993 / NR / Patients with lower extremity edema underwent ultrasound and pulse Doppler scan. All patients had noninvasive evaluation of lower extremities and vena cava was performed before and after discharge. / NR / Survived > 48 hours and had three or more of the following risk factors for PE: age greater than 55 years, Injury Severity Score (ISS) > 15, the presence of severe trauma (Abbreviated Injury Scale (AIS) > 2) of the head, chest, or abdomen, multiple lower extremity fractures, pelvic fractures, spinal trauma, and/or subclavian vein cannulation / NR
Rogers FB, 199539 / Cohort-pros / Single center-N. America / 1991-1994 / NR / To assess for deep vein thrombosis, impedance plethysmography was done within 48 hours of filter insertion and weekly thereafter until death or discharge. Venous duplex ultrasound was used to confirm or rule out DVT if plethysmography was abnormal. / NR / Type of trauma: all trauma patients
Trauma Center
Filter: was placed in one of the four injury groups (spinal cord injury, severe head injury with coma lasting longer than 48 hrs, isolated hip fractures in elderly and complex pelvic fractures with concomitant long bone fracture) and who had relative or absolute contraindications to use of heparin / Elderly patients with isolated hip fractures
Rogers FB, 199738 / Cohort-pros / Single center-N. America / 1991- / NR / Weekly impedance plethysmography / NR / Type of trauma: Pelvis, femur and/or tibial fracture
Trauma Center: Admission to study center
Lower extremity fracture requiring prolonged bed rest >6weeks
Low impact injury or poor chance of survival / NR
Wilson JT, 199455 / Cohort-pros / Single center-N. America / 1986-1993 / 6 Months To 24 Months / Weekly impedance plethysmography / NR / Type of trauma: Traumatic spinal cord injury resulting in paraplegia or quadriplegia
Trauma Center: Admission to study center
Filter: prospective cohort had IVC filter / NR
IVCF Only
Rosenthal D, 200446 / Cohort-retro / Single center-N. America / 2002-2003 / Until Event (Thromboembolic Complication) Occurrence, Discharge Or Death Of Patient / Color flow duplex ultrasound after 2 weeks of IVCF placement / NR / Type of trauma: multiple trauma with relative or absolute contraindications to low dose heparin or barriers to placement of SCD / History of VTE Documented DVT or Pulmonary embolism
Bach JR, 19901 / Case report / Single center-N. America / 1988-1988 / NR / No / NR / NR / NR
Benjamin ME, 19992 / Series / Single center-N. America / NR / Until Discharge Or Death / Weekly duplex imaging / NR / All patients who were referred to the vascular surgery service for filter placement over a six month period were included in the study
Trauma Center
ICU
Binkert CA, 20063 / Cohort-retro / Multiple center- N. America / 2004-2005 / NR / IVC venography at the time of retrieval of filter / NR / Recovery filter removal after more than 180days after placement / NR
Bochicchio GV, 20014 / Case report / Single center-N. America / NR / NR / No / NR / Type of trauma: Building collapse accident: complete open pelvic ring disruption with right acetabular and femur fracture
Type of surgery: Emergent angiography, Exploratory laparotomy for control of bleeding from liver laceration and perforations from the IVCF
Trauma Center
Filter / NR
Carlin AM, 20025 / Cohort-retro / Single center-N. America / 1991-2001 / NR / No / NR / Type of trauma: BLUNT
Trauma Center: Admission to study trauma center
Filter: Prophylactic or therapeutic IVCF placement / NR
Cherry RA, 20086 / Cohort-pros / Single center-N. America / 2004-2006 / NR / No / NR / Age: ≥ 18 years
Trauma Center
Filter: Prophylactic IVC filter placement / Therapeutic IVC filter placement,
major burns,
deviation from a modified EAST protocol,
deaths
Conners MS, 20027 / Cohort-retro / Single center-N. America / 1995-2000 / 1 Year / No / NR / Filter: Duplex-directed IVCF placement / NR
Doody O, 20098 / Cohort-retro / Single center-Australia / 2005-2007 / NR / Venogram at 2 months after filter insertion / NR / NR / NR
Duperier T, 20039 / Cohort-retro / Single center-N. America / 1999-2000 / NR / Duplex before discharge / NR / Filter: Greenfield filter insertion during study period / NR
Gonzalez RP, 200610 / Cohort-pros / Single center-N. America / 1999-2003 / NR / No / NR / Trauma Center: all traumatized patient in the study centre were included
Filter / NR
Greenfield LJ, 200013 / Case series of consecutive patients who received Vena cal filters after Traumatic surgery (from Michigan Filter Registry which contains prospectively collected data for IVCF patients / Single center-N. America / 1990-1999 / Average Follow Up Time Stated In Article Is 42 Months (0-172 Months) / Follow up data obtained prospectively from routine examinations, duplex USS, plain radiographs, and CT scan. / NR / History of VTE Inclusion criteria for therapeutic group in this study
Type of trauma: patients who had trauma as primary or secondary diagnosis during the study period
Trauma Center: all trauma patients who had IVCF Filter / NR
Hermsen JL, 200814 / Cohort-retro / Single center-N. America / 2004-2007 / NR / Preprocedure outpatient computed abdominal tomographic (CAT) scan of the abdomen and pelvis / Government / Trauma Center: level 1 trauma center
Filter: receiving a Bard RecoveryTM or G2TM R-IVCF (Bard Peripheral Vascular, Inc., Tempe, AZ) for PE prophylaxis. / NR
Hoff WS, 200415 / Cohort-pros / Single center-N. America / 2002-2003 / NR / Ultrasound / NR / Head injury (intracerebral hemorrhage) Thoracoabdominal injury
Type of trauma: severe/multiple orthopedic injury Spinal cord injury lower extremity external fixation device/traction device/splints / NR
Hughes GC, 199916 / Case report / Single center-N. America / NR / NR / No / NR / Type of trauma: closed head injury / NR
Kurtoglu M, 200320 / Cohort-pros / Single center-Europe / 1999-2002 / 6 Months, 1 Year, And 2 Years / During follow-up Duplex ultrasound of the inferior vena cava and lower extremity was performed to assess patency / NR / Trauma Center: Trauma and Surgical Emergency Service of Istanbul Medical Faculty
Filter / NR
Langan EM, 199921 / Cohort-pros / Single center-N. America / 1991-1998 / NR / Duplex scans / NR / Immobility: all patients anticipated to have prolonged immobility were eligible for inclusion
All patients with contraindication to anticoagulation were eligible for inclusion
All trauma patients expected to have prolonged immobilization (criteria used to determine this not specified)
All trauma patients with a contraindication to anticoagulation (criteria used to determine this not specified) / NR
Leach TA, 199422 / Cohort-pros / Single center-N. America / 1986-conflicting sentences on page 293: “...During the 5 years beginning July 1986...” and “...During the 6 year study period…” / NR / No / NR / History of VTE
Immobility: Extended Immobilization
Any patient who evidenced 4 or more of the following risk factors for DVT: 1. History of DVT 2.Age >40 years 3. Congestive heart failure 4. Obesity 5. Malignancy 6. Extended immobilization 7. Spinal cord injury:
Any patient exhibiting any one of 1. Previous VTE 2. Free floating ileofemoral thrombus 3. Documented DVT, anticoagulation contraindicated 4 Recent lower extremity venous suture line Trauma Center: Level 1 Trauma Center Filter / NR
Lo CH, 200823 / Series / Single center-Australia / 2001-2005 / NR / No / NR / Filter
Lower limb flap reconstruction(s) / NR
Mahier A, 200824 / Cohort-retro / Single center-Asia / 2002-2005 / NR / Patients with clinical suspicion of VTE had imaging / NR / Trauma Center: tertiary trauma center
Filter
patients who cannot be treated with anticoagulation or suffer from lower extremity trauma precluding the use of pneumatic calf compression / NR
McMurtry AL, 199925 / Cohort-retro / Single center-N. America / 1992; 1989-1996; 1991 / NR / No / NR / Absolute contraindication to coagulation (criteria not stated in the paper)
Trauma Center: all patients admitted with VCFs after trauma / NR
Meier, C., 200627 / Cohort-retro / Single center-Europe / 1998-2004 / NR / No / NR / ISS: ≥16
Filter: Prophylactic IVC filter placement / NR
Meier, C., 200626 / Series / Single center-Europe / 2003- / NR / No / NR / ISS: ≥16 / Filter: Therapeutic filter placement
Millward, S.F., 199428 / Cohort-pros / Multiple center- N. America / 1992-1993 / 1 Month After Filter Removal / The presence of recurrent PE following filter removal was determined by means of clinical assessment. Duplex sonography of the insertion vein and IVC was scheduled to be performed between 1 week and 1 month following filter removal / NR / NR / NR
Nunn, C.R., 199729 / Cohort-pros / Single center-N. America / 1995-1996 / NR / Doppler US of Lower extremities prior to IVC filter placement and after placement looking for DVT / NR / Type of trauma: open abdominal wounds
ISS: >15
Trauma Center: Admission to study center
Filter: Prophylactic Greenfield filter placement / Patients who refused to consent
Offner, P.J., 200331 / Cohort-pros / Single center-N. America / 2001-2002 / Until Death Or Discharge / Duplex sonography was not performed unless clinically indicated by unilateral leg swelling, calf tenderness, tenderness with passive heel stretch, or suspected pulmonary embolism.PE was evaluated using tomography of the chest or formal pulmonary angiography if the tomography was negative. / NR / Patients at high risk for venous thromboembolism with relative or absolute contraindications to low-dose anticoagulant therapy or barriers to the placement of sequential compression devices
Type of trauma: major pelvic and/or acetabular fractures with or without associated lower extremity long bone fractures, bilateral lower extremity long bone fractures, spinal cord injury with neurologic deficit, and severe head injury / NR
Patton, J.H. Jr, 199632 / Cohort-retro / Single center-N. America / 1991-1995 / NR / Duplex ultrasonography was used or patients with suspicion for DVT; patients who exhibited signs of PE were assessed with ventilation/perfusion scan; patients with moderate probability scans were taken to pulmonary angiography if stable enough to leave ICU, otherwise treated as if they had had a PE / NR / Type of trauma: (1) with spinal cord injury and deficit, (2) with pelvic fracture and/or long bone fracture requiring immobilization, and (3) with significant head injury and prolonged immobilization.
Trauma Center
ICU
Filter / NR
Phelan, H.A., 200933 / Series / Single center-N. America / 1992-2001 / NR / No / Industry / Prophylactic permanent Greenfield filters placed after injury, survival to discharge from hospital
Type of trauma: Severe traumatic brain injury, spinal cord injury, major pelvic or lower extremity long bone fracture, pelvic or abdominal penetrating venous injury
Filter: Permanent prophylactic Greenfield filter placement / Age: Less than 18 years at time of study
Preg: Pregnant at time of study
Death before discharge from hospital,
therapeutic filter placement,
prisoners at time of study
Roberts, A., 201035 / Cohort-retro / Single center-N. America / 2003-2009 / 12 Months Post Insertion / No / Industry / Type of trauma: spinal cord injury resulting in quadriplegia or quadriparesis Trauma Center
Filter
severe cervical SCI resulting in quadriplegia or quadriparesis and relative contraindications to anticoagulation relative contraindications to LMWH or UFH (eg. need for spinal surgery stabilization, concomitant injuries such as cranial trauma) / NR
Rogers, F., 200137 / Case report / Single center-N. America / 1999-not stated because this is case report ; patient was discharged from hospital after 45 days / NR / No / NR / Type of trauma: Multiple injuries after falling off a ladder: grade III splenic laceration, Anterior column fracture of 2nd thoracic vertebra, Posterior column fracture of 1st thoracic vertebra, spinal cord lesion Trauma Center
ICU
Filter / NR
Rogers, F.B., 199340 / two studies: one is a retrospective study, the other was prospective / Single center-N. America / 1991-1992 / NR / Weekly impedance plethysmography after filter insertion. If IPG equivocal or abnormal then duplex u/s done / NR / 1. Relative or absolute contraindication to anticoagulants 2. Spinal cord injury with complete paraplegia or quadriplegia 3. Severe Pelvic fracture and long bone fractures; 4. Severe head injury with GCS ≤8
Type of trauma: as stated in inclusion criteria
Glasgow Coma Scale: Severe head injury with a GCS ≤8
Trauma Center: Trauma center Filter / Warfarin therapy
Rogers, F.B., 199741 / Cohort-pros / Single center-N. America / 1991-1996 / Until Hospital Discharge / In the first 2 years of the study, patients underwent impedance plethysmography, duplex sonography or both after 48 hours of VCF insertion and then weekly thereafter till discharge. Later on, patients were only screened for DVT if they developed clinical signs / NR / severe pelvic fracture (type III or IV)
Long bone fracture
Type of trauma: Spinal cord injury with paraplegia or quadriplegia
Glasgow Coma Scale: ≤8
Trauma Center: all patients admitted with contraindication to anticoagulation / NR
Rosenthal, D., 200544 / Cohort-pros / Single center-N. America / 2002-2004 / Until Hospital Discharge Or Death / Yes / NR / Multiple trauma patients with relative or absolute contraindication to anticoagulation (not specified) / NR
Rosenthal, D., 200645 / Cohort-retro / Single center-N. America / 2002-2004 / NR / Lower extremity venous color-flow duplex USS within 14d of placement, and prior to retrieval / NR / Multiple Trauma Patients,
Relative or absolute contra-indications to heparin or barriers to placement of sequential compression devices,
ICU patients, Retrievable filters
Type of trauma: multiple trauma patients
ICU
Filter:
Retrievable (Gunther tulip, recovery and Optease) / NR
Sekharan, J., 200147 / Cohort-retro / Single center-N. America / 1992-1994 / Follow Up Was Attempted In All Patients With At Least 5 Years' Duration Since Placement Of Prophylactic Green Filter / Each patient who presented for follow up had duplex USS to assess presence of DVT / NR / Type of trauma: Severe head injury with prolonged ventilator dependence; Severe head injury with multiple lower extremities fractures; Spinal cord injury with or without paralysis; Major abdominal or pelvic penetrating venous injury; Pelvic fracture with lower extremity fractures
ISS: ISS greater than 9
Trauma Center: Level 1 Filter
Be expected to survive longer than 48 hours / NR
Shang, E.K., 201148 / Case report / Single center-N. America / NR / NR / Yes / Not funded / NR / NR
Sing RF, 200149 / Series / Single center-N. America / NR / Case 2 Was Followed Up For 4years / No / NR / Type of trauma: Multiple trauma
Trauma Center
Filter / NR
Sing RF, 200150 / Prospective Observational study / Single center-N. America / 1996-2000 / Long-Term Follow Up Consists Of Annual Outpatient Visits And Duplex USS Surveillance. / Duplex ultrasonographic surveillance annually / NR / All patients who received IVCF during the study period ,
ICU patients
ICU
Filter / NR
Sing, RF51 / Series / Single center-N. America / NR / NR / No / NR / Immobility
Trauma Center: Admission to study center ICU
Filter: Bedside IVC placement in ICU / NR
Stefanidis D, 200653 / Cohort-pros / Single center-N. America / 2004-2005 / At Least 1 Month Post Hospital Discharge / No / NR / Filter: optional VCF placement / NR
Tola JC, 199954 / Cohort-retro / Single center-N. America / 1997-1998 / Duration Of Hospital Stay / Clinical monitoring for signs and symptoms of PE/venous thrombosis / NR / Severely injured patients with contraindication to anticoagulation (criteria not specified) / NR
Wojcik R, 200056 / Cohort-retro / Single center-N. America / 1993-1997 / NR; The Mean Duration Of Follow Up Is 28.9 months (Range:5-62) / Yes-
Duplex USS / NR / History of VTE: only for patients who had VCF for therapeutic indications
Trauma Center
Patients admitted to trauma service who had VCF placed Filter / NR
Zakhary EM, 200857 / Cohort-retro / Single center-N. America / 2003-2005 / Attempts To Contact Patients Were Made 3 Months After Insertion; The Mean Time Between Insertion Of IVC And Retrieval Was 165 Days (90-360) / No / NR / All patients who had Recovery Filters
Type of trauma
Filters were inserted in blunt trauma patients who had head injury, pelvic fractures and or long bone fractures
Trauma Center: Level 1 trauma center
Filter: Recovery filter excluding patients with new generations recovery filters / Patients with new generations of recovery filters
Patients who received G2 filter which replaced recovery filter
Zolfaghari D, 199558 / Cohort-retro / Single center-N. America / 1990-1991 / NR / Venous duplex scan / NR / All patients who received IVC filter at Level 1 Trauma center
Trauma Center : Level 1
Filter / NR

AIS= Abbreviated Injury Scale; BMI= Body Mass Index; CAT= Computed Axial Tomography; CT= Computed Tomography; CUS= Compression Ultrasonography; DVT= Deep Vein Thrombosis; GCS= Glasgow Coma Scale; ICU= Intensive Care Unit; IPG= Impedance Phlebography; ISS= Injury Severity Score; IVC= Inferior Vena Cava; IVCF= Inferior Vena Cava Filter; LE= Lower Extremity; PE= Pulmonary Embolism; P-IVCF= Prophylactic Inferior Vena Cava Filter; RCT= Randomized Controlled Trial; R-IVCF= Retrievable Inferior Vena Cava Filter; SCD= Sequential Compression Device; SCI= Spinal Cord Injury; TBI= Traumatic Brain Injury; UFH= Unfractionated Heparin; USS= Ultrasound Scan; VCF= Vena Cava Filter; VTE= Venous Thromboembolism