Clinical Evidence

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Clinical Studies In Cardiovascular Surgery

Levitsky S, Rousou J, Gonzalez-Lavin L, et al. Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations, J Thorac Cardiovasc Surg. 1989;97:194-203

Purpose Test the efficacy and safety of fibrin sealant as a topical adjuntive hemostatic agent in patients undergoing either reoperative cardiac surgery or emergency resternotomy.
Methods
  • Open label cross-over study.
  • An earlier formulation of TISSEEL was evaluated against control topical hemostat agents in 489 patients undergoing cardiovascular reoperation or resternotomy at 11 institutions.
  • Patients were randomized to either TISSEEL or control hemostatic agents when topical hemostatic was needed at the conclusion of surgery and after all attempts at surgical hemostasis.
  • 365 of the 489 patients developed bleeding episodes requiring treatment.
Primary Endpoint Successful hemostasis at 5 minutes.
Key Findings
  • For the primary endpoint (successful hemostasis at 5 minutes), TISSEEL was statistically significantly superior to control topical hemostatic agents (p<0.0001).
  • Absolute time to cessation of bleeding was statistically significantly shorter for TISSEEL than for control topical hemostatic agents (p<0.0001).
  • TISSEEL was effective in fully heparinized patients.
Conclusion Fibrin sealant is shown to be safe and highly effective in controlling localized bleeding in cardiac reoperations.

Lowe J, Luber J, Levitsky S, et al. Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery: a phase 3, randomized, double-blind clinical study. J Cardiovasc Surg. 2007;48:323-331.

Purpose Compare the hemostatic efficacy and safety of TISSEEL VH (earlier formulation) and TISSEEL VH S/D (current formulation) in patients undergoing cardiac surgery.
Methods
  • Prospective, parallel design, randomized, double blind, multicenter clinical study.
  • TISSEEL VH S/D evaluated against an earlier formulation of the product (TISSEEL VH) in 317 subjects undergoing cardiac surgery requiring CPB and median sternotomy.
  • Patients were treated with TISSEEL or the control product only when hemostasis was not achieved by conventional methods.
Primary Endpoint Hemostasis at 5 minutes and maintained until surgical closure.
Key Findings
  • TISSEEL VH S/D achieved hemostasis in 5 minutes and maintained hemostasis until surgical closure in 88.2% vs. 89.6% of TISSEEL VH treated patients.
  • TISSEEL VH S/D is non-inferior to the older formulation.
Conclusion
  • TISSEEL VH S/D is effective for use as an adjunct to hemostasis in patients undergoing cardiac surgery requiring CPB.
  • TISSEEL VH S/D was non-inferior to the earlier formulation of the product (TISSEEL VH).

Clinical Study In Colonic Anastomoses

TISSEEL [Fibrin Sealant] full Prescribing Information.

Purpose Investigate the efficacy of fibrin sealant in reducing the incidence of anastomotic complications following the closure of temporary colostomies.
Methods
  • Prospective, randomized single-center trial.
  • An earlier formulation of TISSEELwas evaluated against a control group that did not receive fibrin sealant for colostomy closures.
Primary Endpoint Reduction of anastomotic complications as revealed by leakage, intraabdominal abscess formation, reoperation, septic shock, or death.
Key Findings
  • Patients treated with fibrin sealant directly on the suture lines of colonic anastomoses had fewer complications than those of patients receiving only conventional treatment for the closure of temporary colostomies.
  • The incidence of complications following closure of temporary colostomy was less in the TISSEEL/standard of care group vs. standard of care alone with a significant difference of p=0.0406.
Conclusion TISSEEL fibrin sealant is an effective adjunct to standard surgical techniques(such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Clinical Study In Splenic Trauma

TISSEEL [Fibrin Sealant] full Prescribing Information.

Purpose To assess the efficacy of fibrin sealant in splenic trauma to decrease the need for splenectomy.
Methods
  • Prospective, historically controlled, single-center trial.
  • In patients undergoing laparatomy for blunt or penetrating traumatic injury to the spleen and/or liver, an earlier formulation of TISSEEL was compared to a historical control group that did not receive TISSEEL.
Primary Endpoint Salvation of the spleen.
Key Findings
  • Use of TISSEEL resulted in the need for statistically significantly fewer splenectomies than control hemostasis maneuvers.
  • Results show a 100% salvation of spleens in the TISSEEL group compared to 36% in the historic control group (p<0.001).
Conclusion TISSEEL [Fibrin Sealant] is effective in achieving hemostasis in splenic traumas.