A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery

Jr Renkens K.L., T. D. Payner, T. J. Leipzig, H. Feuer, M. A. Morone, J. M. Koers, K. J. Lawson, R. Lentz, Jr Shuey H., G. L. Conaway, G. B J Andersson, H. S. An, M. Hickey, J. F. Rondinone, N. S. Shargill

Research output: Contribution to journalArticle

130 Citations (Scopus)

Abstract

Study Design. A prospective, randomized trial comparing Proceed™, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. Objectives. To determine the effectiveness and safety of Proceed. Summary of Background Data. Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. Methods. For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. Results. Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. Conclusions. A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.

Original languageEnglish
Pages (from-to)1645-1650
Number of pages6
JournalSpine
Volume26
Issue number15
DOIs
StatePublished - Aug 1 2001

Fingerprint

Hemostatics
Hemorrhage
Absorbable Gelatin Sponge
Hemostasis
Thrombin
Safety
Control Groups
United States Food and Drug Administration
Gelatin
Animal Models
Equipment and Supplies
Therapeutics

Keywords

  • Gelatin-matrix
  • Gelfoam
  • Hemostasis
  • Spinal surgery
  • Thrombin
  • Topical

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Renkens K.L., J., Payner, T. D., Leipzig, T. J., Feuer, H., Morone, M. A., Koers, J. M., ... Shargill, N. S. (2001). A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine, 26(15), 1645-1650. https://doi.org/10.1097/00007632-200108010-00002

A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. / Renkens K.L., Jr; Payner, T. D.; Leipzig, T. J.; Feuer, H.; Morone, M. A.; Koers, J. M.; Lawson, K. J.; Lentz, R.; Shuey H., Jr; Conaway, G. L.; Andersson, G. B J; An, H. S.; Hickey, M.; Rondinone, J. F.; Shargill, N. S.

In: Spine, Vol. 26, No. 15, 01.08.2001, p. 1645-1650.

Research output: Contribution to journalArticle

Renkens K.L., J, Payner, TD, Leipzig, TJ, Feuer, H, Morone, MA, Koers, JM, Lawson, KJ, Lentz, R, Shuey H., J, Conaway, GL, Andersson, GBJ, An, HS, Hickey, M, Rondinone, JF & Shargill, NS 2001, 'A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery', Spine, vol. 26, no. 15, pp. 1645-1650. https://doi.org/10.1097/00007632-200108010-00002
Renkens K.L. J, Payner TD, Leipzig TJ, Feuer H, Morone MA, Koers JM et al. A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine. 2001 Aug 1;26(15):1645-1650. https://doi.org/10.1097/00007632-200108010-00002
Renkens K.L., Jr ; Payner, T. D. ; Leipzig, T. J. ; Feuer, H. ; Morone, M. A. ; Koers, J. M. ; Lawson, K. J. ; Lentz, R. ; Shuey H., Jr ; Conaway, G. L. ; Andersson, G. B J ; An, H. S. ; Hickey, M. ; Rondinone, J. F. ; Shargill, N. S. / A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. In: Spine. 2001 ; Vol. 26, No. 15. pp. 1645-1650.
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abstract = "Study Design. A prospective, randomized trial comparing Proceed™, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. Objectives. To determine the effectiveness and safety of Proceed. Summary of Background Data. Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. Methods. For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. Results. Proceed stopped bleeding in 98{\%} of the patients (first bleeding site only) within 10 minutes, as compared with 90{\%} of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97{\%} of the Proceed group, as compared with 71{\%} of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. Conclusions. A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.",
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AU - Feuer, H.

AU - Morone, M. A.

AU - Koers, J. M.

AU - Lawson, K. J.

AU - Lentz, R.

AU - Shuey H., Jr

AU - Conaway, G. L.

AU - Andersson, G. B J

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N2 - Study Design. A prospective, randomized trial comparing Proceed™, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery. Objectives. To determine the effectiveness and safety of Proceed. Summary of Background Data. Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent. The current study was conducted under a Food and Drug Administration-approved Investigational Device Exemption to evaluate the effectiveness and safety of Proceed in humans. Methods. For this study, 127 patients undergoing spinal surgery were randomized into either the treatment or control group after standard surgical means to control bleeding had failed The bleeding site was evaluated at 1, 2, 3, 6, and 10 minutes after the hemostatic agent was applied. The application was considered successful if the bleeding stopped within 10 minutes. Follow-up evaluation was performed at 12 to 36 hours, then at 6 to 8 weeks after surgery. Results. Proceed stopped bleeding in 98% of the patients (first bleeding site only) within 10 minutes, as compared with 90% of the control patients (P = 0.001). At 3 minutes, successful hemostasis had been achieved in 97% of the Proceed group, as compared with 71% of the control group (P = 0.0001). There was no difference in the adverse event profile between the two groups. Conclusions. A significantly larger number of bleeding sites had achieved hemostasis with Proceed than with Gelfoam-thrombin at 1, 2, and 3 minutes after application. Proceed was as safe as Gelfoam-thrombin when used for hemostasis during spinal surgery procedures.

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