Hemostatic efficacy of fibrin sealant (human) on expanded polytetrafluoroethylene carotid patch angioplasty: A randomized clinical trial

Purpose: The efficacy of solvent-detergent-treated fibrin sealant (human [F SH]) for controlling anastomotic bleeding from expanded polytetrafluoroethy lene (ePTFE) patch angioplasty during carotid endarterectomy was evaluated, and FSH was compared with thrombin-soaked gelatin sponge (Gelfoam; TSG). Methods: The study was of a randomized, open-label, single-site, single-tre atment, parallel design that took place in a referral center with hospitali zed patients, forty-seven adult patients (33 men, 14 women) underwent elect ive carotid endarterectomy. Patients were randomized to receive either FSH (N = 24) or TSG (N = 23). FSH was obtained as an investigational new drug. FSH was applied as a liquid by means of a dual-syringe technique. Heparin a nticoagulation, patch thickness, and suture type were standardized. Two dif ferent needle sizes were used (CV-6, PT-13: N = 21 [FSH: N = 10, TSG: N = 1 1]; CV-6, PT-9: N = 26 [FSH: N = 14, TSG: N = 13]). The FSH or TSG was appl ied to the ePTFE patch, and then blood flow was restored through the caroti d artery. Degree of anticoagulation was assessed by anti-factor Xa activity . The time from restoration of carotid blood flow until achieving hemostasi s was recorded. The blood loss from patch suture hole bleeding was measured . Completion intraoperative duplex ultrasound scanning was performed in all cases. Heparin was reversed with protamine sulfate. The primary end point was successful hemostasis within 15 minutes of restoration of carotid blood flow. The secondary end points were the amount of blood loss caused by sut ure line bleeding and the time to achieve hemostasis. Results: There was no difference in the number of patients with complete he mostasis at 15 minutes (TSG, 13 of 23; FSH, 12 of 24; P =.77). The measured blood loss was 99.0 +/- 119.9 (SD) mt for TSG, and 105.0 +/- 107.9 mt for FSH (P =.86). The time to hemostasis was the same for both groups (TSG, 16. 5 +/- 16.5 minutes; FSH, 16.6 +/- 14.2 minutes; P =.97). Within both treatm ent groups, the use of larger needles (PT-13) was associated with greater b lood loss (FSH, 169.7 +/- 124.2 mL; TSG, 172.7 +/- 151.5 mL) than was the u se of smaller needles (PT-9; FSH, 58.8 +/- 66.3 mL; TSG, 34.1 +/- 25.6 mL; P =.036, P =.001, respectively). There were no postoperative strokes or ble eding com plications in either group. No abnormalities were shown in either group by means of completion carotid duplex ultrasound scanning. Conclusion: FSH was equivalent, but not superior to, TSG in achieving hemos tasis during carotid endarterectomy performed with ePTFE patch angioplasty. Adhesion properties of FSH to ePTFE are possibly different than those to n ative tissue and warrant additional investigation.