PMID- 37427979
OWN - NLM
STAT- MEDLINE
DCOM- 20230712
LR  - 20230810
IS  - 2047-7163 (Electronic)
IS  - 0036-8504 (Print)
IS  - 0036-8504 (Linking)
VI  - 106
IP  - 3
DP  - 2023 Jul-Sep
TI  - Fibrin Sealant TISSEEL Lyo as a haemostatic agent in vascular surgery: Results of 
      randomized, controlled, patient-blinded, multicentre clinical study in the 
      Russian population.
PG  - 368504231182834
LID - 10.1177/00368504231182834 [doi]
LID - 00368504231182834
AB  - BACKGROUND: This phase III, controlled, patient-blinded, multicentre study in two 
      parallel, equal-sized treatment groups compared the efficacy and safety of 
      TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze 
      pads for use as a haemostatic agent in patients who underwent vascular surgery in 
      Russia. METHODS: Adult patients, both genders, who received peripheral vascular 
      expanded polytetrafluoroethylene conduits and had suture line bleeding after 
      surgical haemostasis were enrolled. Patients were randomized to be treated with 
      TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be 
      assessed as grade 1 or 2 bleeding according to the Validated Intraoperative 
      Bleeding scale. The primary efficacy endpoint was the proportion of patients 
      achieving haemostasis at 4 min after treatment application (T(4)) at the study 
      suture line, which was maintained until the closure of the surgical wound. The 
      secondary efficacy endpoints included the proportion of patients achieving 
      haemostasis at 6 min (T(6)) and 10 min (T(10)) after treatment application at the 
      study suture line, which was maintained until closure of the surgical wound, as 
      well as the proportion of patients with intraoperative and postoperative 
      rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical 
      site infections and graft occlusions. RESULTS: A total of 110 patients were 
      screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 
      [51%] patients). T(4) haemostasis was achieved in 43 (84.3%) patients in the 
      TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). 
      Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T(6) 
      (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 
      1.37; 2.35]) and T(10) (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had 
      intraoperative rebleeding. Postoperative rebleeding was reported only in one 
      patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to 
      TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were 
      reported in patients during the study. CONCLUSIONS: Data demonstrated TISSEEL Lyo 
      had clinically and statistically significant superiority to MC as a haemostatic 
      agent in vascular surgery at all measured time points including 4, 6 and 10 min 
      and had proven to be safe.
FAU - Karpenko, Andrey A
AU  - Karpenko AA
AD  - National Research Center Named after Academician E.N. Meshalkin, Novosibirsk, 
      Russia.
FAU - Cheban, Alexey V
AU  - Cheban AV
AUID- ORCID: 0000-0002-6094-4607
AD  - National Research Center Named after Academician E.N. Meshalkin, Novosibirsk, 
      Russia.
FAU - Rabtsun, Artem A
AU  - Rabtsun AA
AD  - National Research Center Named after Academician E.N. Meshalkin, Novosibirsk, 
      Russia.
FAU - Sokurenko, German Y
AU  - Sokurenko GY
AD  - A.M. Nikiforov All-Russian Center of Emergency and Radiation Medicine, 
      St-Petersburg, Russia.
FAU - Andreychuk, Konstantin A
AU  - Andreychuk KA
AD  - A.M. Nikiforov All-Russian Center of Emergency and Radiation Medicine, 
      St-Petersburg, Russia.
FAU - Kim, Igor N
AU  - Kim IN
AD  - State Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia.
FAU - Volf, Valentin A
AU  - Volf VA
AD  - State Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia.
FAU - Kuznetsov, Maksim R
AU  - Kuznetsov MR
AD  - Institute of Cluster Oncology Named after L. L. Levshin of the Sechenov 
      University, Moscow, Russia.
AD  - City Clinical Hospital Named after S. S. Yudin, Moscow, Russia.
FAU - Prostov, Igor I
AU  - Prostov II
AD  - Rostov State Medical University, Rostov-on-Don, Russia.
FAU - Sapronova, Natalia G
AU  - Sapronova NG
AD  - Rostov State Medical University, Rostov-on-Don, Russia.
FAU - Mzhavanadze, Nina D
AU  - Mzhavanadze ND
AUID- ORCID: 0000-0001-5437-1112
AD  - Ryazan State Medical University Named after Academician I.P. Pavlov, Ryazan, 
      Russia.
FAU - Kamaev, Alexey A
AU  - Kamaev AA
AD  - Ryazan State Medical University Named after Academician I.P. Pavlov, Ryazan, 
      Russia.
FAU - Suchkov, Igor A
AU  - Suchkov IA
AUID- ORCID: 0000-0002-1292-5452
AD  - Ryazan State Medical University Named after Academician I.P. Pavlov, Ryazan, 
      Russia.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Sci Prog
JT  - Science progress
JID - 0411361
RN  - 0 (Fibrin Tissue Adhesive)
RN  - 0 (Hemostatics)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Female
MH  - Male
MH  - Fibrin Tissue Adhesive/therapeutic use
MH  - *Surgical Wound/drug therapy/etiology
MH  - Blood Loss, Surgical/prevention & control
MH  - *Hemostatics/therapeutic use
MH  - Vascular Surgical Procedures/adverse effects
PMC - PMC10358634
OTO - NOTNLM
OT  - Fibrin sealant
OT  - TISSEEL Lyo
OT  - surgery
OT  - thrombin
COIS- The author(s) declared no potential conflicts of interest with respect to the 
      research, authorship, and/or publication of this article.
EDAT- 2023/07/10 13:05
MHDA- 2023/07/12 06:42
PMCR- 2023/07/10
CRDT- 2023/07/10 09:13
PHST- 2023/07/12 06:42 [medline]
PHST- 2023/07/10 13:05 [pubmed]
PHST- 2023/07/10 09:13 [entrez]
PHST- 2023/07/10 00:00 [pmc-release]
AID - 10.1177_00368504231182834 [pii]
AID - 10.1177/00368504231182834 [doi]
PST - ppublish
SO  - Sci Prog. 2023 Jul-Sep;106(3):368504231182834. doi: 10.1177/00368504231182834.