| Methods |
Study: RCT
Exclusion to post‐randomisation: 0
Losses to follow up: 18 (10 in the treatment group and 8 in the control group)
DVT diagnosis: CDU of proximal and distal veins at day 10 ± 2
Statistical analysis: odds ratio and NNT
Scheduled treatment and follow‐up period: 10 ± 2 days; follow up at 30 and 90 days |
| Participants |
Country: France
Total number of participants: 151
Total available for analysis: 133
Age: mean 59.9 (±14.7) years in the treatment group and 65.7 (±12.7) years in the control group; P < 0.01
Sex: males 62% (46/74) in the treatment group and 55% (42/77) in the control group
Immobilisation: no
Inclusion criteria: age over 18 years, traumatic or spontaneous ICH with or without SAH
Exclusion criteria: extra or subdural haematomas, traumatic ICH due to polytrauma including the lower limbs, haemorrhagic transformation of ischaemic infarct and vasculitis, DVT within the previous 3 months, lower‐limb arteriopathy, venous graft, wound in the lower limb related either to a vascular disease or a trauma, 'do not resuscitate' order, and > 24‐hour delay since hospital admission
Full intention‐to‐treat analysis: not performed |
| Interventions |
Type: intermittent pneumatic compression (SC Response Controller) plus GCS (TED) versus GCS (TED) alone. ICP applied sequentially for 11 seconds with pressures of 45, 40 and 30 mmHg at the ankle, calf and thigh. GCS length not stated
Control: 77
Treatment: 74
Duration applied: 10 ± 2 days |
| Outcomes |
DVT
Control: 11
Treatment: 3
P value: 0.03 |
| Notes |
The study included both traumatic and spontaneous ICH, with (or without) SAH, and the authors did not give any additional information on the number of spontaneous ICH and their outcome. The control group wore GCS. Immobilisation was not an inclusion criteria. Control group patients were significantly younger than the treatment group patients
18.9% patients (14/74) in the treatment group did not tolerate the IPC device |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
A ‐ Adequate. Computer‐generated with random block sizes and stratified according to three variables (age, surgical intervention plan, admission to intensive care unit) |
| Allocation concealment? |
Low risk |
A ‐ Adequate. Sequentially numbered, sealed, opaque envelopes |
| Blinding?
All outcomes |
Low risk |
A ‐ Adequate. Intermittent pneumatic compression device removed before CDU was performed
CDU scans were recorded on videotape for independent blind assessment |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
A ‐ Adequate. 18 patients did not have the scheduled compression duplex ultrasound |
