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Study Title Principal Investigator
A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surgeries
The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.
Completed | Hemostatics | Multisite
Linda Sher
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A PHASE 3, RANDOMIZED, SINGLE-BLIND, CONTROLLED TRIAL OF TOPICAL FIBROCAPS" IN INTRAOPERATIVE SURGICAL HEMOSTASIS. (FINISH-3).
Completed | Hemostatics | Multisite
Linda Sher
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A randomized, open label, parallel-group, multi-center trial to compareefficacy and safety of TachoSil® versus Surgicel® Original for the secondaryhemostatic treatment of needle hole bleeding in vascular surgery.
The drug being tested in this study is called TachoSil®. TachoSil® was used to treat people undergoing scheduled subacute vascular surgery. This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches. The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio: - TachoSil® - Surgicel® Original This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 6 months. Participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.
Completed | Hemostatics | Multisite
Vincent Rowe
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