NCT01662856 - Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery | Biotech Hunter

Enrollment

225

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions

Vascular 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).

PROCEDURE

Manual Compression

Direct manual compression of target bleeding site with gauze/laparotomy pads.

Trial Locations (38)

8200

502, Veszprém

11000

523, Belgrade

11030

406, Manhasset

11040

521, Belgrade

11794

113, Stony Brook

15212

100, 128, Pittsburgh

19611

115, West Reading

20889

135, Bethesda

21000

522,524, Novi Sad

21201

129, Baltimore

30303

140, Atlanta

32207

149, Jacksonville

32216

148, Jacksonville

33606

137, Tampa

35630

407, Florence

40536

110, Lexington

43606

104, Toledo

45409

409, Dayton

52242

114, Iowa City

53792

111, Madison

70112

132, New Orleans

70809

146, Baton Rouge

76107

147, Fort Worth

77024

402, Houston

92120

119, San Diego

94304

125, Palo Alto

98104

103, Seattle

98431

138, Tacoma

194354

541, Saint Petersburg

195271

543, Saint Petersburg

197374

544, Saint Petersburg

344022

542, Rostov-on-Don

630055

540, Novosibirsk

02118

102, Boston

10467-2401

142, The Bronx

84132-3201

139, Salt Lake City

03526

501, Miskolc

07623

500, Pécs

All Listed Sponsors

lead

Instituto Grifols, S.A.

INDUSTRY