Allogeneic single‐donor cryoseal produced from fresh‐frozen quarantine apheresis plasma as alternative for multidonor or autologous fibrin sealants

Hazelaar, Sandra; Dijkstra‐Tiekstra, Margriet J.; Korte, Dirk de; Wildt‐Eggen, J. de

doi:10.1111/j.1537-2995.2011.03315.x

Cited by 7 publications

(5 citation statements)

References 20 publications

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“…CryoSeal® is an allogeneic single‐donor fibrin sealant produced from fresh frozen quarantined plasma from donations of non‐remunerated volunteers. It is produced by the Sanquin Blood Bank using disposables provided by Recuperate Medical (Recuperate Medical, Haren, The Netherlands). CryoSeal® consists of two components: cryoprecipitate and thrombin.…”

Section: Methodsmentioning

confidence: 99%

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study)

Tavilla

Bruggemans

Gielen

et al. 2015

British Journal of Surgery

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Section: Methodsmentioning

confidence: 99%

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study)

Tavilla

Bruggemans

Gielen

et al. 2015

British Journal of Surgery

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“…Investigators evaluated fresh frozen apheresis plasma as a source of allogeneic single donor fibrin sealant using the methods provided in the Cryoseal System (CS-1, Asahi Kasei Medical Co., Ltd., Chiyoda, Tokyo, Japan) which employs cryoprecipitation to derive fibrinogen as well as precipitation by CaCl 2 and ethanol to obtain thrombin [104]. Evidence supporting the manufacturing consistency and ability to obtain useful levels of clotting factors, particularly fibrinogen and thrombin was presented.…”

Section: Fibrin Sealant Laboratory Literaturementioning

confidence: 99%

Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive—a Laboratory and Clinical Perspective

2014

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Background. Fibrin sealant became the first modern era material approved as a hemostat in the United States in 1998. It is the only agent presently approved as a hemostat, sealant, and adhesive by the Food and Drug Administration (FDA). The product is now supplied as patches in addition to the original liquid formulations. Both laboratory and clinical uses of fibrin sealant continue to grow. The new literature on this material also continues to proliferate rapidly (approximately 200 papers/year). Methods. An overview of current fibrin sealant products and their approved uses and a comprehensive PubMed based review of the recent literature (February 2012, through March 2013) on the laboratory and clinical use of fibrin sealant are provided. Product information is organized into sections based on a classification system for commercially available materials. Publications are presented in sections based on both laboratory research and clinical topics are listed in order of decreasing frequency. Results. Fibrin sealant remains useful hemostat, sealant, and adhesive. New formulations and applications continue to be developed. Conclusions. This agent remains clinically important with the recent introduction of new commercially available products. Fibrin sealant has multiple new uses that should result in further improvements in patient care.

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“…Patients were randomized to receive either intra-articular topical Cryoseal ™ fibrin sealant (CS) or standard care without an intra-articular hemostat [ 15 ]. A method of computer generated per-center randomization using permutated blocks with randomly differing block-sizes was used (ProMISe ™ software; Leiden University Medical Center).…”

Section: Methodsmentioning

confidence: 99%

“…Cryoseal ™ fibrin sealant (CS) is produced by Sanquin, The Netherlands [ 15 ]. CS is derived from one unit of fresh frozen plasma donated by a single donor.…”

Section: Methodsmentioning

confidence: 99%

The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial

et al. 2018

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BackgroundTotal knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully extended knee is less strenuous, we hypothesized that patients who received fibrin sealant would demonstrate improved early knee extension after six weeks compared to patients who received standard care.MethodsA multicenter randomized controlled trial in a consecutive series of osteoarthritis patients scheduled for TKR surgery. Participants were randomized to receive fibrin sealant or not before closing the knee joint capsule. Primary outcome was change in knee extension angle(°) at short term (2 weeks) follow-up (cExt). Secondary outcomes were 6-week extension angle, knee flexion angle, hemoglobin loss, blood transfusion rates, complication rates, the Knee Society Score, and the KOOS and EQ5D questionnaires.ResultsWhen data on primary outcome became available from 250 patients, an interim analysis was performed by an independent Data Safety Monitoring Board for safety and effectivity assessment. This analysis showed that sufficient patients were included to detect a cExt of 10° between both groups. Inclusion was stopped however, all in the meantime included patients were treated according to their randomization. A total of 466 were available for analysis. Both groups were comparable in terms of baseline characteristics. The estimated mean cExt difference was 0.2° (95%CI -0.5 to 0.9). No differences in secondary outcomes were found.ConclusionsNo beneficial effects or side effects were found of a topically applied fibrin sealant during TKR surgery. These results discourage the clinical use of a fibrin sealant in TKR.Trial registrationDutch Trial Register, NTR2500.

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Allogeneic single‐donor cryoseal produced from fresh‐frozen quarantine apheresis plasma as alternative for multidonor or autologous fibrin sealants

Abstract: The cryoseal manufacturing process resulted in a consistent product, which meets the predetermined specifications. The single-donor origin and the absence of fibrinolytic inhibitors make cryoseal a good alternative for multidonor and autologous fibrin sealants.

Cited by 7 publications

References 20 publications

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study)

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study)

Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive—a Laboratory and Clinical Perspective

The effect of a fibrin sealant on knee function after total knee replacement surgery. Results from the FIRST trial. A multicenter randomized controlled trial

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