Clinical trials, systematic review and meta-analyses, and observational studies
| Study . | Study design . | Studies . | Population . | Intervention . | Comparator . | Efficacy outcomes . | Safety outcomes . |
|---|---|---|---|---|---|---|---|
| Clinical trials | |||||||
| Fullen et al 19734 | Quasi-RCT | N/A | Traumatic fracture of the proximal femur without VTE | Permanent IVCF (n = 41) | No IVCF (n = 59) | PE: 4 (10%) in IVCF group vs 19 (32%) in non-IVCF group Mortality: 4 (10%) in IVCF group vs 14 (24%) in non-IVCF group | IVCF complications: none reported in either group |
| Rajasekhar et al 20115 | Randomized pilot feasibility study | N/A | High-risk trauma patient without VTE | Retrievable IVCF and anticoagulant prophylaxis (n = 18) | Standard anticoagulant VTE prophylaxis (n = 16) | PE: 0 in IVCF group vs 1 in non-IVCF group | DVT: 1 in IVCF group vs 0 in non-IVCF group |
| Mortality: 1 in IVCF group vs 0 in non-IVCF group | IVCF retrieval: 0% at 3 mo; 15% at 6 mo | ||||||
| Ho et al 20191 | RCT | N/A | High-risk trauma patient (ISS > 15) without VTE and contraindication to AC | Retrievable IVCF (n = 122) | No IVCF (n = 118) | 90-d composite symptomatic PE or mortality: 17 (13.9%) in IVCF group vs 17 (14.4%) in non-IVCF group (HR 0.99; 95% CI 0.51-1.94; P = .98) | Symptomatic PE (after 7 d with continued contraindication to AC): 0 in IVCF group vs 5 in non-IVCF group (RR 0, 95% CI 0.00-0.55) |
| Mortality: 16 (13.1%) of IVCF group vs 11 (9.3%) of non-IVCF group (RR 1.41; 95% CI 0.69-2.87) | IVCF complications (at time of filter retrieval): 15% | ||||||
| 90-d IVCF retrieval: 71 of 108 (66%) | |||||||
| Systematic reviews and meta-analyses | |||||||
| Rajasekhar et al 20113 | Systematic review and meta-analysis | 7 observational cohort studies | High-risk trauma patient without VTE | IVCF (n = 428) (6 studies with permanent IVCFs, 1 not reported) and anticoagulant prophylaxis (in 5 studies) | No IVCF (n = 1472) and anticoagulant prophylaxis (in 5 studies) | PE: 4 of 428 (0.9%) in IVCF group vs 76 of 1472 (5%) in non-IVCF group (OR 0.21; 95% CI 0.09-0.49) | DVT*: 17 of 94 (18%) in IVCF group vs 18 of 138 (13%) in non-IVCF group (OR 1.6; 95% CI 0.76-3.37) |
| Singh et al 20136 | Systematic review and meta-analysis | 8 controlled studies: 1 pilot feasibility, 7 observational; 2 excluded from meta-analysis | Mixed trauma patient | IVCF (2 permanent IVCF; 6 not reported) (n = 432) | No IVCF (i.e. mechanical ± anticoagulant prophylaxis) (n = 4160) | PE*: 2 of 334 (0.5%) in IVCF group vs 48 of 730 (6.5%) in non-IVCF group (RR 0.20; 95% CI 0.06-0.70) | Fatal PE*: 0 of 163 (0%) in IVCF group vs 20 of 407 (4.9%) in non-IVCF group (RR 0.09; 95% CI 0.01-0.81) |
| Mortality*: 21 of 166 (12.6%) in IVCF group vs 60 of 312 (19.2%) in non-IVCF group (RR 0.7; 95% CI 0.4-1.23) | DVT*: 18 of 112 (16%) in IVCF group vs 18 of 154 (11.7%) in non-IVCF group (RR 1.76; 95% CI 0.49-6.18; P = .38) | ||||||
| Filter complication* 1.0%-5.7% | |||||||
| Haut et al 20147 | Systematic review and meta-analysis | 8 controlled studies: 1 pilot feasibility, 7 observational – 2 excluded from meta-analysis | Mixed trauma patient | IVCF and standard VTE prophylaxis (n = 334) | Standard VTE prophylaxis (n = 730) | PE: 2 (0.5%) in IVCF group vs 48 (6.5%) in non-IVCF group (RR 0.20; 95% CI 0.06-0.70) | Fatal PE*: 0 in IVCF group vs 20 of 407 (4.9%) in non-IVCF group (RR 0.09; 95% CI 0.01-0.81) |
| Mortality*: RR 0.70 [95% CI 0.4-1.23] | DVT*: RR 1.76; 95% CI 0.50-6.19, P = .38) | ||||||
| Shariff et al 20208 | Systematic review and meta-analysis | 10 controlled studies: 2 RCTs, 8 observational studies | High-risk trauma patients (ISS > 15 or trauma delaying initiation of VTE prophylaxis) | IVCF (n = 573) | Standard VTE prophylaxis (n = 1717) | Symptomatic PE: 5 (0.87%) in IVCF group vs 90 (5.2%) in non-IVCF group (RR 0.27; 95% CI 0.12-0.58; P < 0.05) | Fatal PE*: 0 in IVCF group vs 23 of 619 (3.7%) in non-IVCF group (RR 0.29; 95% CI 0.08-1.10; P = .07) |
| Observational studies | |||||||
| Batty et al 20129 | Prospective cohort study with concurrent controls | N/A | High-risk trauma patient without VTE | IVCF (n = 511) | No IVCF (n = 5833) | PE: OR 0.28; 95% CI 0.088-0.890; P = .031 | NR |
| Hemmila et al 201510 | Retrospective cohort study | N/A | High-risk trauma patient without VTE | IVCF (n = 803) | No IVCF (n = 39456) | PE: 9 (1.1%) in IVCF group vs 187 (0.5%) in non-IVCF group (P = .01) | DVT: 54 (6.7%) in IVCF group vs 483 (1.2%) in non-IVCF group (P < .001) |
| Mortality: 42 (5.2%) in IVCF group vs 1369 (3.5%) in non-IVCF group (P = .01) | |||||||
| Sarosiek et al 201711 | Retrospective cohort study | N/A | High-risk trauma patient without VTE | IVCF (n = 451) | No IVCF (n = 1343) | Mortality: IVCF group with higher mortality than non-IVCF group (P = .14) | NR |
| Study . | Study design . | Studies . | Population . | Intervention . | Comparator . | Efficacy outcomes . | Safety outcomes . |
|---|---|---|---|---|---|---|---|
| Clinical trials | |||||||
| Fullen et al 19734 | Quasi-RCT | N/A | Traumatic fracture of the proximal femur without VTE | Permanent IVCF (n = 41) | No IVCF (n = 59) | PE: 4 (10%) in IVCF group vs 19 (32%) in non-IVCF group Mortality: 4 (10%) in IVCF group vs 14 (24%) in non-IVCF group | IVCF complications: none reported in either group |
| Rajasekhar et al 20115 | Randomized pilot feasibility study | N/A | High-risk trauma patient without VTE | Retrievable IVCF and anticoagulant prophylaxis (n = 18) | Standard anticoagulant VTE prophylaxis (n = 16) | PE: 0 in IVCF group vs 1 in non-IVCF group | DVT: 1 in IVCF group vs 0 in non-IVCF group |
| Mortality: 1 in IVCF group vs 0 in non-IVCF group | IVCF retrieval: 0% at 3 mo; 15% at 6 mo | ||||||
| Ho et al 20191 | RCT | N/A | High-risk trauma patient (ISS > 15) without VTE and contraindication to AC | Retrievable IVCF (n = 122) | No IVCF (n = 118) | 90-d composite symptomatic PE or mortality: 17 (13.9%) in IVCF group vs 17 (14.4%) in non-IVCF group (HR 0.99; 95% CI 0.51-1.94; P = .98) | Symptomatic PE (after 7 d with continued contraindication to AC): 0 in IVCF group vs 5 in non-IVCF group (RR 0, 95% CI 0.00-0.55) |
| Mortality: 16 (13.1%) of IVCF group vs 11 (9.3%) of non-IVCF group (RR 1.41; 95% CI 0.69-2.87) | IVCF complications (at time of filter retrieval): 15% | ||||||
| 90-d IVCF retrieval: 71 of 108 (66%) | |||||||
| Systematic reviews and meta-analyses | |||||||
| Rajasekhar et al 20113 | Systematic review and meta-analysis | 7 observational cohort studies | High-risk trauma patient without VTE | IVCF (n = 428) (6 studies with permanent IVCFs, 1 not reported) and anticoagulant prophylaxis (in 5 studies) | No IVCF (n = 1472) and anticoagulant prophylaxis (in 5 studies) | PE: 4 of 428 (0.9%) in IVCF group vs 76 of 1472 (5%) in non-IVCF group (OR 0.21; 95% CI 0.09-0.49) | DVT*: 17 of 94 (18%) in IVCF group vs 18 of 138 (13%) in non-IVCF group (OR 1.6; 95% CI 0.76-3.37) |
| Singh et al 20136 | Systematic review and meta-analysis | 8 controlled studies: 1 pilot feasibility, 7 observational; 2 excluded from meta-analysis | Mixed trauma patient | IVCF (2 permanent IVCF; 6 not reported) (n = 432) | No IVCF (i.e. mechanical ± anticoagulant prophylaxis) (n = 4160) | PE*: 2 of 334 (0.5%) in IVCF group vs 48 of 730 (6.5%) in non-IVCF group (RR 0.20; 95% CI 0.06-0.70) | Fatal PE*: 0 of 163 (0%) in IVCF group vs 20 of 407 (4.9%) in non-IVCF group (RR 0.09; 95% CI 0.01-0.81) |
| Mortality*: 21 of 166 (12.6%) in IVCF group vs 60 of 312 (19.2%) in non-IVCF group (RR 0.7; 95% CI 0.4-1.23) | DVT*: 18 of 112 (16%) in IVCF group vs 18 of 154 (11.7%) in non-IVCF group (RR 1.76; 95% CI 0.49-6.18; P = .38) | ||||||
| Filter complication* 1.0%-5.7% | |||||||
| Haut et al 20147 | Systematic review and meta-analysis | 8 controlled studies: 1 pilot feasibility, 7 observational – 2 excluded from meta-analysis | Mixed trauma patient | IVCF and standard VTE prophylaxis (n = 334) | Standard VTE prophylaxis (n = 730) | PE: 2 (0.5%) in IVCF group vs 48 (6.5%) in non-IVCF group (RR 0.20; 95% CI 0.06-0.70) | Fatal PE*: 0 in IVCF group vs 20 of 407 (4.9%) in non-IVCF group (RR 0.09; 95% CI 0.01-0.81) |
| Mortality*: RR 0.70 [95% CI 0.4-1.23] | DVT*: RR 1.76; 95% CI 0.50-6.19, P = .38) | ||||||
| Shariff et al 20208 | Systematic review and meta-analysis | 10 controlled studies: 2 RCTs, 8 observational studies | High-risk trauma patients (ISS > 15 or trauma delaying initiation of VTE prophylaxis) | IVCF (n = 573) | Standard VTE prophylaxis (n = 1717) | Symptomatic PE: 5 (0.87%) in IVCF group vs 90 (5.2%) in non-IVCF group (RR 0.27; 95% CI 0.12-0.58; P < 0.05) | Fatal PE*: 0 in IVCF group vs 23 of 619 (3.7%) in non-IVCF group (RR 0.29; 95% CI 0.08-1.10; P = .07) |
| Observational studies | |||||||
| Batty et al 20129 | Prospective cohort study with concurrent controls | N/A | High-risk trauma patient without VTE | IVCF (n = 511) | No IVCF (n = 5833) | PE: OR 0.28; 95% CI 0.088-0.890; P = .031 | NR |
| Hemmila et al 201510 | Retrospective cohort study | N/A | High-risk trauma patient without VTE | IVCF (n = 803) | No IVCF (n = 39456) | PE: 9 (1.1%) in IVCF group vs 187 (0.5%) in non-IVCF group (P = .01) | DVT: 54 (6.7%) in IVCF group vs 483 (1.2%) in non-IVCF group (P < .001) |
| Mortality: 42 (5.2%) in IVCF group vs 1369 (3.5%) in non-IVCF group (P = .01) | |||||||
| Sarosiek et al 201711 | Retrospective cohort study | N/A | High-risk trauma patient without VTE | IVCF (n = 451) | No IVCF (n = 1343) | Mortality: IVCF group with higher mortality than non-IVCF group (P = .14) | NR |
AC, anticoagulation; CI, confidence interval; HR, hazard ratio; ISS, Injury Severity Score; N/A, not applicable; NR, not reported; OR, odds ratio; RR, relative risk.
Outcome not reported in all studies.