Fibrocaps for surgical hemostasis: Two randomized, controlled phase II trials

Cornelis Verhoef, Neil Singla, Greg Moneta, William Muir, Arjen Rijken, Harry Lockstadt, Johannes H.W. De Wilt, Albert Yurvati, Linda A. Zuckerman, Paul Frohna, Robert J. Porte

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. Conclusions Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.

Original languageEnglish
Pages (from-to)679-687
Number of pages9
JournalJournal of Surgical Research
Volume194
Issue number2
DOIs
StatePublished - 1 Jan 2015

Fingerprint

Surgical Hemostasis
Porifera
Gelatin
Netherlands
Hemostasis
Fibrin Tissue Adhesive
Safety
Antithrombins
Thrombin
Powders
Fibrinogen
Blood Vessels
Dissection
Hemorrhage
Equipment and Supplies
Antibodies
Liver
Incidence
Therapeutics

Keywords

  • Dry powder
  • Fibrin sealant
  • Fibrinogen and thrombin
  • Hepatic surgery
  • Soft tissue dissection
  • Spinal surgery
  • Vascular surgery

Cite this

Verhoef, C., Singla, N., Moneta, G., Muir, W., Rijken, A., Lockstadt, H., ... Porte, R. J. (2015). Fibrocaps for surgical hemostasis: Two randomized, controlled phase II trials. Journal of Surgical Research, 194(2), 679-687. https://doi.org/10.1016/j.jss.2014.12.011
Verhoef, Cornelis ; Singla, Neil ; Moneta, Greg ; Muir, William ; Rijken, Arjen ; Lockstadt, Harry ; De Wilt, Johannes H.W. ; Yurvati, Albert ; Zuckerman, Linda A. ; Frohna, Paul ; Porte, Robert J. / Fibrocaps for surgical hemostasis : Two randomized, controlled phase II trials. In: Journal of Surgical Research. 2015 ; Vol. 194, No. 2. pp. 679-687.
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abstract = "Background Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83{\%} versus 35{\%}, P < 0.001; FC-002 NL: 77{\%} versus 53{\%}, P = 0.11), 5 min (94{\%} versus 61{\%}, P = 0.001; 95{\%} versus 71{\%}, P = 0.022), and 10 min (100{\%} versus 78{\%}, P = 0.003; 100{\%} versus 82{\%}, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5{\%} of Fibrocaps-treated patients on day 29. Conclusions Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.",
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author = "Cornelis Verhoef and Neil Singla and Greg Moneta and William Muir and Arjen Rijken and Harry Lockstadt and {De Wilt}, {Johannes H.W.} and Albert Yurvati and Zuckerman, {Linda A.} and Paul Frohna and Porte, {Robert J.}",
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Verhoef, C, Singla, N, Moneta, G, Muir, W, Rijken, A, Lockstadt, H, De Wilt, JHW, Yurvati, A, Zuckerman, LA, Frohna, P & Porte, RJ 2015, 'Fibrocaps for surgical hemostasis: Two randomized, controlled phase II trials', Journal of Surgical Research, vol. 194, no. 2, pp. 679-687. https://doi.org/10.1016/j.jss.2014.12.011

Fibrocaps for surgical hemostasis : Two randomized, controlled phase II trials. / Verhoef, Cornelis; Singla, Neil; Moneta, Greg; Muir, William; Rijken, Arjen; Lockstadt, Harry; De Wilt, Johannes H.W.; Yurvati, Albert; Zuckerman, Linda A.; Frohna, Paul; Porte, Robert J.

In: Journal of Surgical Research, Vol. 194, No. 2, 01.01.2015, p. 679-687.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Fibrocaps for surgical hemostasis

T2 - Two randomized, controlled phase II trials

AU - Verhoef, Cornelis

AU - Singla, Neil

AU - Moneta, Greg

AU - Muir, William

AU - Rijken, Arjen

AU - Lockstadt, Harry

AU - De Wilt, Johannes H.W.

AU - Yurvati, Albert

AU - Zuckerman, Linda A.

AU - Frohna, Paul

AU - Porte, Robert J.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. Conclusions Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.

AB - Background Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. Materials and methods Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). Results Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. Conclusions Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.

KW - Dry powder

KW - Fibrin sealant

KW - Fibrinogen and thrombin

KW - Hepatic surgery

KW - Soft tissue dissection

KW - Spinal surgery

KW - Vascular surgery

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Verhoef C, Singla N, Moneta G, Muir W, Rijken A, Lockstadt H et al. Fibrocaps for surgical hemostasis: Two randomized, controlled phase II trials. Journal of Surgical Research. 2015 Jan 1;194(2):679-687. https://doi.org/10.1016/j.jss.2014.12.011