Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
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
1 other identifier
interventional
181
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
May 10, 2017
CompletedJune 14, 2017
May 1, 2017
1.9 years
December 12, 2013
March 30, 2017
May 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
From start of treatment until 5 minutes after treatment start
Secondary Outcomes (2)
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
From start of treatment until 4 minutes after treatment start
Prevalence of Treatment Failures
From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes
Study Arms (4)
IG1202-A (Vascular)
EXPERIMENTALIG1202-B (Hepatic)
EXPERIMENTALIG1202-C (Soft Tissue)
EXPERIMENTALIG1202-D (Spinal)
EXPERIMENTALInterventions
Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Eligibility Criteria
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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
805
Tucson, Arizona, 85712, United States
602
Los Angeles, California, 90048, United States
700, 801
Pasadena, California, 91105, United States
803
Boulder, Colorado, 80303, United States
908
Hartford, Connecticut, 06102, United States
601
Washington D.C., District of Columbia, 20007, United States
507
Gainesville, Florida, 32611, United States
501, 901
Jacksonville, Florida, 32216, United States
604
Evanston, Illinois, 60208, United States
804
Lexington, Kentucky, 40509, United States
905
Baltimore, Maryland, 21201, United States
902
Jackson, Mississippi, 39216, United States
800
Las Vegas, Nevada, 89144, United States
600
New York, New York, 10029, United States
606
Poughkeepsie, New York, 12601, United States
508
Chapel Hill, North Carolina, 27599, United States
503
Fort Worth, Texas, 76107, United States
900
Houston, Texas, 77024, United States
605
Salt Lake City, Utah, 84132, United States
802
Spokane, Washington, 99208, United States
Related Publications (1)
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.
PMID: 31376435DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Henry Li, PhD
- Organization
- Grifols Therapeutics Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2013
First Posted
December 18, 2013
Study Start
December 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
June 14, 2017
Results First Posted
May 10, 2017
Record last verified: 2017-05