Martin 2002.
Methods | Design: randomized controlled trial Withdrawals: none Setting: single centre (USA) Sample size: 90 |
|
Participants | Age (mean): 6% Hetastarch in normal saline 58, 6% Hetastarch in balanced saline 59, lactated Ringer’s solution 58 Gender (M/F): not described ASA grade: I to III Surgery type: major elective non‐cardiac surgery with anticipated blood loss of 500 mL Surgery duration (mean): not described Anaesthesia type: general |
|
Interventions | Three arms, only 2 of which are included (60 participants) 30 patients were enrolled into the buffered (Hextend) arm; and 30 into the non‐buffered arm (Hespan). Trial fluids were given according to a protocol, to ensure adequate volume during the operation. In addition, each arm was given a maintenance dose of lactated Ringer's solution (a buffered fluid). |
|
Outcomes | TEG data measured before induction, at end of surgical procedure, and 24 hours postoperatively | |
Notes | These are the same participant data as in Moretti 2003, but different outcomes are reported. Funding source: supported in part by a grant from BioTime, Inc. Declarations of interest: none disclosed |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded to participants, trial conductors and assessors |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded to participants, trial conductors and assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant in each group fell out ‐ 1 did not need study fluid, the other had surgery rescheduled. |
Selective reporting (reporting bias) | Low risk | No evidence of selection bias. All proposed outcome measures adequately reported. Analysis completed on an intention‐to‐treat basis |
Other bias | Unclear risk | Study was funded in part by BioTime Inc., which manufactures Hextend. |