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

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.

Timeline

Start

2013-12

Primary completion

2015-11

Completion

2015-11

Outcome

Met primary endpoint

paper response ratio: 0.973; 95% CI 0.833 to 1.135 PMID 31376435 ↗

paper the TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI. PMID 31376435 ↗

Publications

• Minkowitz H, Navarro-Puerto J, Lakshman S, Singla S, Cousar C, Kim R, Villavicencio A, Kirksey L, Ayguasanosa J; Clinical Investigation Study Group on Topical Thrombin (Human) Grifols in Surgery. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery. J Am Coll Surg. 2019 Nov;229(5):497-507.e1. doi: 10.1016/j.jamcollsurg.2019.07.008. Epub 2019 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bovine Thrombin	Protein / enzyme biologic	—	Topical
Subject	Human Thrombin	Protein / enzyme biologic	—	Topical

Indications