Table 1.
Summary of design and patient characteristics
| Author year | Country (sites) | Design | Population | Time between injury and recruitment/ immobilization duration (mean) | Prophylaxis before randomization | Intervention | Comparator | Outcome measure (primary) |
|---|---|---|---|---|---|---|---|---|
| Goel et al.28 | Canada (NR) | R, DBa | Adults (18‐75 y; mean age, 41 y; male, 62%). Fractures below knee. Surgically treated Outpatients N = 305 | Within 48h Immobilization duration: 14 db | No | LMWH (dalteparin, 5000 IU/d for 14 d; administered by s.c. injection; compliance, >95%) | Matching placebo for 14 d (compliance with injections, >95%) | Incidence of DVT determined by bilateral venography at end of treatment |
| Jørgensen et al., 2002 29 | Denmark (3 centers) | R, OLa | Adults (>18 y; mean age, 48 y; male, 57%) Fracture or soft‐tissue injury; Conservative or surgically treated Outpatients N = 300 | NR Immobilization duration: 5.5 weeks | No | LMWH (tinzaparin, 3500 IU/d for duration of cast immobilization; administered by s.c. injection; compliance, NR) | No treatment | Incidence of DVT determined by unilateral venography after plaster cast removal |
| Kock et al., 199530 | Germany (NR) | R, OL | Adults (18‐75 y; mean age, 34 y; male, 61%) Fracture or soft‐tissue injury Conservative treatment Outpatients N = 428 | NR Immobilization duration: 17 db | No | LMWH (certoparin, 3000 IU/d for duration of cast immobilization; administered by s.c. injection; compliance, NR) | No treatment | Incidence of DVT determined by duplex sonography and confirmed by phlebography after plaster cast removal |
| Kujath et al., 1993 31 | Germany (1 hospital) | R, OL | Patients over 16 y (mean age, 34 y; male, 58%) Fracture or soft‐tissue injury Conservative treatment Outpatients N = 306 | NR Immobilization duration: 15.7 db | No | LMWH (Nadroparin, 2850 IU/d for duration of cast immobilization; administered by s.c. injection; compliance, NR) | No treatment | Incidence of DVT determined by compression ultrasound and phlebography (positive findings only) after plaster cast removal |
| Lapidus et al., 2007a 32 | Sweden (1 centra) | R, DBa | Adults (18‐75 y; mean age, 40 y; male, 79%) Soft‐tissue injury (Achilles tendon rupture) Surgically treated Outpatients N = 105 | Within 72 h of injury Immobilization duration: 43 db | No | LMWH (dalteparin, 5000 IU/d for 6 weeks; administered by s.c. injection; compliance, NR) | Matching placebo for 6 weeks (compliance with injections, NR) | Incidence of DVT determined by unilateral duplex sonography and confirmed by phlebography |
| Lapidus et al., 2007b 33 | Sweden (1 centra) | R, DBa | Adults (18‐75 y; mean age, 48 y; male, 46%) Fracture of the ankle Surgically treated Outpatients N = 272 | Within 72 h of injury Immobilization duration: 44 db | Yes, all patients received 1 week of initial treatment with dalteparin (5000 IU/d) before randomization | LMWH (dalteparin, 5000 IU/d for 5 weeks; administered by s.c. injection; compliance, 94.6%) | Matching placebo for 5 weeks (compliance with injections, 94.6%) | Incidence of DVT confirmed by unilateral phlebography after cast removal or compression ultrasonography where the phlebography failed |
| Lassen et al., 2002 k34 | Denmark (6 hospitals) | R, DBa | Adults (>18 y; median age, 47 y; male, 52%) Fracture or rupture of the Achilles tendon Conservative or surgically treated Outpatient (in most cases) N = 440 | |||||
| Within 4 d of injury Immobilization duration: 44 db | Yes, approximately one‐third in each group received other LMWH for up to 4 d before randomization | LMWH (reviparin, 1750 IU/d for duration of cast immobilization; administered by s.c. injection; compliance, approximately 100%) | Matching placebo for duration of cast immobilization (compliance with injections, approximately 100%) | Incidence of DVT determined by unilateral venography after plaster cast removal (or earlier if clinical symptoms of thrombosis suspected) | ||||
| Selby et al., 2015 8 | Canada (13 hospitals) | R, DBa | Patients over 16 y (mean age, 49 y; male, 52%) fractures Surgically treated Outpatients N = 265 | Within 72 h of injury Immobilization duration: 43 db | No | LMWH (dalteparin, 5000 IU/d for 14 d; administered by s.c. injection; compliance, 90%) | Matching placebo for 14 d (compliance with injections, 92%) | Symptomatic VTE within 3 months after surgery or asymptomatic proximal DVT determined by bilateral Doppler ultrasound at end of treatment |
| van Adrichem et al., 2017 36 | The Netherlands (8 hospitals) | R, OLa | Adults (>18 y; mean age, 46 y; male, 49.9%) Fracture or soft‐tissue injury Conservative or surgically treated Outpatients N = 1519 | NR Immobilization duration: 4.9 weeksb | No | LMWH (nadroparin, 2850 IU/d or dalteparin, [2500 IU/d for <100 kg or 5000 IU/d >100 kg] for duration of cast immobilization; administered by s.c. injection; compliance, 87%) | No treatment | Incidence of symptomatic VTE within 3 months after the procedure. DVT determined by abnormal compression ultrasound |
| Zheng et al., 2017 6 | China (3 hospitals) | R, DBa | Adults (>18 y; mean age, 47.8 y; male, 62.3%) Fracture of the ankle or foot Surgically treated Outpatients N = 814 | Mean 3.3 d Immobilization duration: NR | No | LMWH (NR but given once daily for 14 d; administered by s.c. injection; compliance, NR) | Matching placebo for 14 d (compliance with injections, NR) | Incidence of VTE. DVT determined by bilateral Doppler ultrasound |
| Gehling et al., 1998 27 | Germany (1 hospital) | R | Patients over 16 y (mean age, 36 y; male, 49%) Fracture or soft‐tissue injury Management approach unclear (but majority appear to be surgically treated) Outpatients N = 287 | NR Immobilization duration: NR | NR | LMWH (reviparin, 1750 IU/d administered by s.c. injection; compliance, NR) | Aspirin (1000 mg/d administered orally; compliance, NR) | Incidence of DVT determined by duplex sonography (all) or phlebography (if thrombosis suspected) |
| Bruntink et al., 2017 (3‐arm study) 9 | The Netherlands (7 hospitals) | R, SBa | Adults (>18 y; mean age, 47 y; male, 42%) Fracture of the ankle or foot Conservative treatment Outpatients N = 467 | Within 72 h of injury Immobilization duration: 39.5 db | No | LMWH nadroparin, 2850 IU/d for duration of cast immobilization; administered by s.c. injection; compliance approximately 100%) | 1. Fondaparinux (2.5 mg/d for duration of cast immobilization; administered by s.c. injection; compliance, approximately 100%) 2. No treatment | Incidence of DVT determined by duplex sonography after the removal of the cast (or earlier if thrombosis was suspected) |
| Samama et al., 2013 35 | France, Russia, The Netherlands, Spain, Germany, Italy (93 centers) | R, OLa | Adults (>18 y; mean age, 46 y; male, 46.6%) Fracture or soft‐tissue injury Conservative treatment Outpatients N = 1349 | Within 72 h of injury Immobilization duration: 33.7 db | No | LMWH (nadroparin, 2850 IU/d for duration of cast immobilization; administered by s.c. injection; compliance, NR) | Fondaparinux (2.5 mg/d for duration of cast immobilization; administered by s.c. injection; compliance, NR) | Incidence of VTE. Compression ultrasonography and/or venography performed for suspected DVT after cast removal |
Abbreviations: DB, double blind; DVT, deep vein thrombosis; LMWH, low molecular weight heparin; NR, not reported; OL, open label; R, randomized controlled trial; SB, single blind; s.c, subcutaneous; VTE, venous thromboembolism.
a
Blinded outcome assessment.
b
Means calculated from reported group means of intervention and comparator arms.