Surgical Bleeding Clinical Trial
Official title:
A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixaâ„¢ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
Verified date | February 2020 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
Status | Terminated |
Enrollment | 55 |
Est. completion date | March 6, 2018 |
Est. primary completion date | November 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility |
Before Surgery Inclusion Criteria: - Was at least 36 weeks gestational age at birth (if an infant less than 6 months old) and is no older than 17 years at time of treatment - Has a legal representative (parent or guardian) who signed an institutional review board (IRB)-approved informed consent document - If at least 7 years old or appropriate age as defined by local regulations, may be required to sign an IRB-approved assent document - Is scheduled to undergo one of the surgical procedures described in the protocol - If female and of child-bearing potential, subject has negative pregnancy test on the day of surgery (baseline) - If a sexually active male or female of reproductive potential, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits During Surgery Inclusion Criteria: - Has mild or moderate bleeding/oozing - Has TBS surface area no more than 100 cm^2 - Has not received any whole blood, fresh frozen plasma (FFP), cryoprecipitate, or platelets within 24 hours prior to study drug (packed red blood cell (PRBC) transfusions are allowed) - Had no complication during surgery other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety Exclusion Criteria: - Has any clinically significant laboratory or vital sign value, chronic disease state, or congenital coagulation disorder (eg, hemophilia A or B) that the investigator determines could interfere with the assessment of efficacy or pose a safety risk to the participant - Is unwilling to receive blood products - Has known antibodies or hypersensitivity to porcine gelatine, Raplixa or any of it's components, or other thrombin preparations or coagulation factors - Has medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety of the participant or compliance with study procedures, including protocol-defined limits on participating in other clinical studies |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois |
United States | Children's Medical Center Dallas | Dallas | Texas |
United States | Nemours Children's Specialty Care | Jacksonville | Florida |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Arizona Burn Center at Maricopa Medical Center | Phoenix | Arizona |
United States | Carilion Clinic | Roanoke | Virginia |
United States | Shriners Hospital for Children | Sacramento | California |
United States | Saint Louis Children's Hospital | Saint Louis | Missouri |
United States | Seattle Children's Hospital - PIN | Seattle | Washington |
United States | SGM Physician Research Consortium, LLC | Wayne | Pennsylvania |
United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Mallinckrodt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes | Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application | within 4 minutes | |
Secondary | Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes | Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application | within 5 minutes | |
Secondary | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) | Clinically significant changes in safety measures are recorded as adverse events. Participants with TEAEs that are deemed by the principal investigator or the independent data monitoring committee as possibly or definitely treatment-related (including device-related) are included in the count for this secondary outcome measure. | within 97 days |
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