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

Completed · Phase 2

Conditions studied: Hemostasis

In brief

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.

Key facts

Study ID

NCT02014402

Run by

Instituto Grifols, S.A.

People needed

181

Starts

2013-12-01

Expected to finish

2015-11-01

Last updated by the study team

2017-06-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter)
• Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional method).
• Required one of the following procedures:
• 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).
• A target bleeding site (TBS) was identified according to the Investigator's judgment, and the TBS had mild or moderate bleeding according to the Investigator's judgment.

You may not qualify if…

• Required surgical procedure due to trauma (except for spinal surgery).
• Infection in the anatomic surgical area.
• History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
• Previous known sensitivity to any Topical Thrombin (Human) Grifols component, any Bovine Thrombin JMI component, porcine collagen, and heparin or protamine (vascular surgery only) component.
• Received an organ transplant.
• Underwent another concurrent major surgical intervention beyond the liver (applied to hepatic surgery [IG1202-B] only; concurrent interventions on the pancreas, gall bladder, bile duct, or intestines were allowed).
• Underwent a re-operative procedure, which was defined as a second, or successive, surgical procedure on the same anatomic location.
• Underwent other vascular procedures during the same surgical session (applied to vascular surgery [IG1202-A] only; stenting and/or endarterectomy of the same artery were allowed).
• Underwent a therapeutic surgical procedure within 30 days from screening (diagnostic procedures were allowed).
• Previously included in this trial (i.e. each subject could only be enrolled once in this study).
• TBS could not be identified according to the investigator's judgment.
• TBS had a severe bleeding according to the Investigator's judgment.
• Occurrence of major intra-operative complications that required resuscitation or deviation from the planned surgical procedure.
• Application of any topical haemostatic material on the resection surface of the liver prior to application of the study treatment (applied to hepatic surgery [IG1202-B] only).
• Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment (applied to hepatic surgery [IG1202-B] only).
• Intra-operative change in planned surgical procedure which resulted in subject no longer meeting preoperative inclusion and/or exclusion criteria.
• Application of any topical haemostatic material on the cut soft tissue surface prior to application of the study treatment (applied to soft tissue surgery [IG1202-C] only).

Where it is running

• 805 — Tucson, Arizona, United States
• 602 — Los Angeles, California, United States
• 700, 801 — Pasadena, California, United States
• 803 — Boulder, Colorado, United States
• 908 — Hartford, Connecticut, United States
• 601 — Washington D.C., District of Columbia, United States
• 507 — Gainesville, Florida, United States
• 501, 901 — Jacksonville, Florida, United States
• 604 — Evanston, Illinois, United States
• 804 — Lexington, Kentucky, United States
• 905 — Baltimore, Maryland, United States
• 902 — Jackson, Mississippi, United States
• 800 — Las Vegas, Nevada, United States
• 600 — New York, New York, United States
• 606 — Poughkeepsie, New York, United States
• 508 — Chapel Hill, North Carolina, United States
• 503 — Fort Worth, Texas, United States
• 900 — Houston, Texas, United States
• 605 — Salt Lake City, Utah, United States
• 802 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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