Skip to main content
. 2023 Aug 8;2023(8):CD010872. doi: 10.1002/14651858.CD010872.pub2

Fischer 2011.

Study characteristics
Methods Study design: randomised trial
Follow‐up: not reported
Participants Setting: European multicentre trial (10 centres)
Number randomised: 121 (2 participants excluded postrandomisation)
Interventions Intervention: TachoSil (n = 60)
  • TachoSil, a sterile, ready‐to‐ use, absorbable surgical patch consisting of an equine collagen sponge coated with human fibrinogen and human thrombin measuring 9.5 x 4.8 x 0.5 cm, was applied on the resection surfaces after being moistened with physiological saline. The yellow‐coated side (active side) of the patch was held against the resection surface for 3 minutes to ensure uniform contact. The resection site(s) had to be covered at least 1 cm beyond its margin, and if > 1 patch was needed, they had to overlap. TachoSil treatment could be repeated after 5 to 8 minutes.


Control: argon beam coagulator (ABC: n = 59)
  • Management of bleeding with the ABC was done according to the routine of the centres. All hepatic resection areas were treated, and treatment was repeated if haemostasis was not achieved within 5 minutes. The duration and number of treatments were recorded.


Co‐interventions: escape treatment was applied if haemostasis was not obtained within 10 minutes after the application of study treatment. No specific escape treatment was defined, but was chosen according to local protocols
Outcomes Primary outcome: time to haemostasis
Secondary outcomes
  • Total drainage volume

  • Total postoperative duration of drainage

  • Drain fluid haemoglobin and bilirubin

  • Measurement (with ultrasound) volume of blood/liquid at resection surface

Notes 2 participants were excluded postrandomisation due to incorrect randomisation.
6 participants discontinued the study due to adverse events (2 in TachoSil group, 4 in ABC group).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Centralised telephone randomisation system.
Allocation concealment (selection bias) Low risk Centralised telephone randomisation system.
Blinding of participants and personnel (performance bias)
All outcomes High risk Assessors not blinded to allocation.
Blinding of outcome assessment (detection bias)
All outcomes High risk Participants and personnel not blinded.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No follow‐up protocol specified.
Selective reporting (reporting bias) Low risk All relevant outcomes reported.
Other bias Low risk No other bias identified.