Mild or Moderate Surgical Bleeding Clinical Trial
— FINISH-3Official title:
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
| NCT number | NCT01527357 |
| Other study ID # | FC-004 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 21, 2012 |
| Est. completion date | June 1, 2013 |
| Verified date | July 2016 |
| Source | Mallinckrodt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as
compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical
bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to
moderate bleeding by standard surgical techniques is ineffective and/or impractical.
| Status | Completed |
| Enrollment | 721 |
| Est. completion date | June 1, 2013 |
| Est. primary completion date | April 24, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document 2. Is undergoing one of the 4 surgical procedures described 3. Is at least 18 years old at time of consent 4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding 5. If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse 6. Has not received blood transfusion between screening and study treatment 7. Has mild to moderate surgical bleeding 8. Does not have intra-operative complications 9. Has not used a topical hemostat containing thrombin prior to study treatment 10. Has an approximate bleeding site surface area of less than or equal to 100 cm^2 Exclusion Criteria: 1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors 2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required) 3. Has known allergy to gelatin sponge 4. Is unwilling to receive blood products 5. Has liver enzymes appropriate for the study, considering their disease 6. Has appropriate level of platelets per liter (PLT/L) during screening 7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Militair Hospitaal Koningin Astrid | Brussells | |
| Belgium | Clinique du Parc Leopold, Service de Neurochirurgie | Bruxelles | |
| Belgium | Hopital Erasme, Service de Neurochirurgie | Bruxelles | |
| Belgium | Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde | Gent | |
| Belgium | Universitair Ziekenhuis Leuven, Abdominale Heelkunde | Leuven | |
| Netherlands | Amphia Hospital | Breda | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | University Medical Centre Groningen | Groningen | |
| Netherlands | Leiden University Medical Center | Leiden | |
| Netherlands | Radboud University Medical Center | Nijmegen | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| Netherlands | Rijnstate Arnhem | Velp | |
| United Kingdom | Queen Elizabeth Hospital Birmingham | Birmingham | England |
| United Kingdom | Addenbrookes Hospital Vascular Department | Cambridge | England |
| United Kingdom | Doncaster Royal Infirmary | Doncaster | England |
| United Kingdom | Hull Royal Infirmary | Hull | England |
| United Kingdom | Leeds General Infirmary | Leeds | England |
| United Kingdom | King's College Hospital | London | England |
| United Kingdom | Freeman Hospital | Newcastle upon Tyne | England |
| United States | Overlake Hospital Medical Center | Bellevue | Washington |
| United States | Cardio-Thoracic Surgeons, PC | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Boulder Neurological Institute | Boulder | Colorado |
| United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
| United States | Indiana Spine Group | Carmel | Indiana |
| United States | Northwestern University | Chicago | Illinois |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Spine Colorado | Durango | Colorado |
| United States | Duke University Hospital Medical Center | Durham | North Carolina |
| United States | University of North Texas Health Sciences Center | Fort Worth | Texas |
| United States | Borgess Research Institute | Kalamazoo | Michigan |
| United States | William Muir MD Spine Surgery | Las Vegas | Nevada |
| United States | Bluegrass Orthopedics | Lexington | Kentucky |
| United States | University of Southern California, Keck School of Medicine | Los Angeles | California |
| United States | University of Southern California/Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | New York-Presbyterian Hospital/Columbia University | New York | New York |
| United States | Vascular Interventional Specialists of Orange County | Orange | California |
| United States | Lotus Clinical Research, LLC | Pasadena | California |
| United States | Oregon Health & Science University Hospital & Clinics | Portland | Oregon |
| United States | Beaumont Health System | Royal Oak | Michigan |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Physician's Research Options | Sandy | Utah |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | NorthShore University HealthSystem | Skokie | Illinois |
| United States | Northwest Orthopaedic Specialists, P.S. | Spokane | Washington |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Multicare Neuroscience Center of Washington | Tacoma | Washington |
| United States | The University of Oklahoma - Tulsa | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Mallinckrodt |
United States, Belgium, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery | The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment. | Within 5 minutes | |
| Primary | Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery | The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment. | Within 5 minutes | |
| Primary | Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection | The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment. | Within 5 minutes | |
| Primary | Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection | The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment. | Within 5 minutes | |
| Secondary | Restricted Mean TTH | Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment. | Within 5 minutes | |
| Secondary | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date. | Within 29 days | |
| Secondary | Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes | If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures. | At 5 minutes | |
| Secondary | Number of Participants Who Required Red Blood Cells | Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted". | Within 29 days |