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. 2023 Aug 8;2023(8):CD010872. doi: 10.1002/14651858.CD010872.pub2

Bjelović 2018.

Study characteristics
Methods Study design: randomised trial
Follow‐up: 90 days from date of surgery
Participants Setting: multicentre (Hungary, Serbia, Spain, USA)
Number randomised: 325
Interventions Intervention: Fibrin Sealant Grifols (n = 163)
  • Fibrin Sealant Grifols is composed of frozen solutions of highly purified human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL) with calcium chloride (5.9 mg/mL) supplied as a ready‐to‐use kit, in preloaded glass syringes assembled on a syringe holder. For the specific use on the surface of hepatic resections, the fibrin sealant was delivered using spray applicator tips (Gas Assisted Applicator Kit, 5 cm3. Micromedics, Inc. Eagan, MN, USA). Grifols fibrin sealant was applied onto the target bleeding site surface by spraying (10 cm distance with a 1–1.75 bar pressure) in short bursts (0.1–0.2 mL). The maximum total volume of Grifols fibrin sealant was 12 mL (2 kits).


Control: oxidised cellulose sheets (Surgicel; n = 162)
Outcomes Primary outcome: proportion of participants who achieved haemostasis at the target bleeding site by 4 minutes without rebleeding until completion of surgical closure. Rebleeding was defined as bleeding from the target bleeding site requiring a further haemostatic intervention after haemostasis was previously achieved.
Secondary outcomes
  • Time to haemostasis in minutes

  • Cumulative proportion of participants achieving haemostasis at the target bleeding site after 2 minutes, 3 minutes, 4 minutes, 5 minutes, 7 minutes, 10 minutes

  • Prevalence of treatment failures (persistent bleeding beyond 4 minutes, rebleeding before completion of surgical closure, brisk and forceful bleeding that jeopardised participant safety, or requirement of alternative haemostatic treatments of manoeuvre during the 10‐minute observation period)

Notes 9 participants discontinued the study (Fibrin Sealant Grifols n = 5, Surgicel n = 4), with reasons not specified.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation software.
Allocation concealment (selection bias) Low risk Randomisation software.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel not blinded to outcome.
Blinding of outcome assessment (detection bias)
All outcomes High risk Participants and personnel not blinded to outcome.
Incomplete outcome data (attrition bias)
All outcomes Low risk Adequate follow‐up and outcome data provided.
Selective reporting (reporting bias) Low risk All relevant outcomes were reported, and reasons for exclusion stated.
Other bias Low risk No other bias identified.