Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

PHASE3CompletedINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Parenchymous Tissue Surgical Bleeding
Interventions
BIOLOGICAL

Fibrin Sealant Grifols

Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.

DEVICE

Surgicel®

Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Trial Locations (33)

1082

602, Budapest

7623

600, Pécs

10029

211, New York

10032

212, New York

11000

621, 622, 623, Belgrade

12208

200, Albany

17033

400, Hershey

18000

620, 625, Niš

19102

218, Philadelphia

19107

204, Philadelphia

20889

229, Bethesda

21000

624, Novi Sad

22908

226, Charlottesville

28204

230, Charlotte

29425

205, Charleston

30912

223, Augusta

38104

217, Memphis

40202

207, Louisville

45219

233, Cincinnati

46526

227, Goshen

53792

202, Madison

60611

228, Chicago

63110

201, St Louis

70112

220, New Orleans

77030

216, 219, Houston

84132

232, Salt Lake City

89102

231, Las Vegas

90033

214, Los Angeles

92354

224, Loma Linda

115478

640, Moscow

197758

641, Saint Petersburg

06520

213, New Haven

37232-7610

206, Nashville

All Listed Sponsors
lead

Instituto Grifols, S.A.

INDUSTRY

NCT01754480 - Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries | Biotech Hunter | Biotech Hunter