Schallom 2012.
| Study characteristics | ||
| Methods | Design: RCT, open‐label Exclusions post‐randomisation: heparin group: n = 5; saline group: n = 1 Losses to follow‐up: heparin group: n = 9; saline group: n = 1 Duration of study: From April 2009 to May 2010 Unit of randomisation: catheter | |
| Participants | Country: USA Setting: medical or surgical ICU patients Number: 338 (heparin group: n = 172; saline group: n = 166) Age: heparin group: 59.1 ± 15.2; saline group: 58.3 ± 17.5 Sex: heparin group: male/female 68/104; saline group: male/female 83/83 Inclusion criteria: patients had to have a newly inserted (< 12 hrs) multi‐lumen CVC. Exclusion criteria: patients with multi‐lumen dialysis or apheresis catheters, PICC, long‐term use catheters, pulmonary artery catheters, implanted ports, large‐bore single lumen sheath catheters, and multi‐lumen catheters threaded through large bore sheath catheters; patients with double‐lumen catheters; known heparin allergy; diagnosis of HIT, bleeding risk identified by attending physician; age < 18 yrs; and pregnancy | |
| Interventions | Flushes every 8 hours with:
Prophylactic or therapeutic anticoagulation was used in both groups with non‐significant differences. |
|
| Outcomes | Rate of lumen non‐patency, blood loss return, flush failure, rate of catheter‐related bloodstream infection, HIT Follow‐up: 22 days | |
| Funding | Not reported | |
| Declarations of interest | Not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Investigators used a computerised random number generator in MS Excel. |
| Allocation concealment (selection bias) | Low risk | Quote: "The allocation sequence was concealed until the card was retrieved upon obtaining patient consent". |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label study. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Open‐label study. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 2/166 in saline group and 14/172 in heparin group withdrew. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol was not available, but it was clear that published reports included all expected outcomes, including those that were prespecified. |
| Other bias | Unclear risk | Not enough information to permit judgement of other bias |
BMT: blood and marrow transplantation CI: confidence interval CVC: central venous catheter h: hours HIT: heparin‐induced thrombocytopaenia ICU: intensive care unit KVO: keep vein open LMWH: low molecular weight heparin MODS: multi‐organ dysfunction syndrome NaCl: sodium chloride PICCs: peripherally inserted central catheters PT: prothrombin time PTT: partial thromboplastin time RCT: randomised controlled trial RICU: respiratory intensive care unit SD: standard deviation SVC: superior vena cava TIVAD: totally implantable vascular access device TPN: total parenteral nutrition