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

Hemostasis Clinical Trial

Official title:
A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgeries

Clinical Trial Summary

This purpose of this clinical trial is 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 open surgical procedures. Approximately 180 subjects will be treated with either Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI® (60 subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by standard surgical techniques is ineffective or impractical and requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.

Clinical Trial Description

This is a prospective, randomized, double-blind, controlled, Phase II study to evaluate the safety and efficacy of Topical Thrombin (Human) Grifols as an adjunct to hemostasis during vascular (IG1202-A), hepatic (IG1202-B), soft tissue (IG1202-C), and spinal (IG1202-D) open surgical procedures. Approximately 180 subjects will be randomized into 1 of 2 treatment groups in a 2:1 ratio: Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI (60 subjects) among the 4 types of surgeries. Randomized subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by conventional surgical techniques (including suture, ligature and cautery) is ineffective or impractical and requires an adjunct treatment to achieve hemostasis. The Investigator will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will be applied to the TBS and hemostasis will be assessed at various timepoints during a 5-minute observation period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02014402
Study type Interventional
Source Grifols Biologicals Inc.
Contact
Status Completed
Phase Phase 2
Start date December 2013
Completion date November 2015
View Details
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