CompletedPhase 2

Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery

United States181 participantsStarted 2013-12

Plain-language summary

This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.

Who can participate

SexALL

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Inclusion criteria

✓. An elective (non-emergency), open (non-laparoscopic; non- endovascular) surgical procedure involving a native artery-graft end-to-side proximal anastomosis utilizing coated or uncoated polytetrafluoroethylene (PTFE) graft (IG1202-A).
✓. An elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic and non-anatomic resections of at least one anatomical hepatic segment or equivalent tissue volume) (IG-1202-B).
✓. An elective (non-emergency), open (non-laparoscopic), surgical procedure involving soft (non-parenchymous) tissue (IG1202-C).
✓. An elective (non-emergency), spinal surgical procedure in which the epidural venous plexus was exposed (IG1202-D).

What they're measuring

Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS

Timeframe: From start of treatment until 5 minutes after treatment start

Trial details

NCT IDNCT02014402

SponsorInstituto Grifols, S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2017-03-30

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