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Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.

Abstract：

BACKGROUND:We evaluated safety and immunogenicity observations pooled from 8 clinical trials of recombinant human thrombin (rThrombin), an active topical hemostatic agent. STUDY DESIGN:Recombinant thrombin was applied with an absorbable gelatin sponge or spray applicator during a surgical procedure (day 1). Adverse events and laboratory parameters were monitored until study end (day 29). Immunogenicity was evaluated after study completion on plasma samples collected at baseline and on day 29. RESULTS:Studies included 583 rThrombin-treated patients (median age, 59 years; 54% men). Surgical procedures included: spinal, 33% of patients; hepatic resection, 14%; peripheral arterial bypass, 23%; arteriovenous graft formation for hemodialysis access, 18%; and skin graft after burn wound excision, 12%. Adverse events reported for >or= 10% patients included incision site pain, procedural pain, nausea, constipation, pyrexia, anemia, insomnia, vomiting, and pruritus. Five of 552 patients developed antibodies to rThrombin (0.9%; 95% CI, 0.3 to 2.1; day 29); antibodies did not neutralize the biologic activity of native human thrombin. At baseline, 12 patients had pre-existing, antibodies recognizing rThrombin (12 of 552; 2.2%; 95% CI, 1.1 to 3.8); these patients had no previous exposure to rThrombin and their antibody titer did not increase >or= 1.0 unit (>or= 10-fold) at day 29. CONCLUSIONS:Results from 8 clinical trials collectively demonstrated that rThrombin is well tolerated in numerous surgical settings when used as a topical adjunct to hemostasis. Adverse events and changes in laboratory parameters were consistent with commonly reported postoperative events. Less than 1% of patients developed antibodies to rThrombin; the antibodies did not neutralize native human thrombin.

journal_name

J Am Coll Surg

journal_title

Journal of the American College of Surgeons

authors

Ballard JL,Weaver FA,Singla NK,Chapman WC,Alexander WA

doi

10.1016/j.jamcollsurg.2009.09.042

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

199-204

issue

eissn

1072-7515

issn

1879-1190

pii

S1072-7515(09)01458-6

journal_volume

210

pub_type

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Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin.