Excessive Bleeding During Surgery Clinical Trial
Official title:
A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
| Verified date | April 2023 |
| Source | Grifols Therapeutics LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).
| Status | Completed |
| Enrollment | 186 |
| Est. completion date | May 20, 2022 |
| Est. primary completion date | April 15, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility | Inclusion Criteria: Pre-operative: 1. Less than 18 years of age. 2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure. 3. Participant and/or participant's legal guardian is willing to give permission for the participant to participate in the clinical trial and provide written informed consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the clinical trial. Intra-operative: 4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon). 5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the investigator's (the surgeon's) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale. Exclusion Criteria: Pre-operative: 1. Admitted for trauma surgery. 2. Unwilling to receive blood products. 3. Known history of severe (eg, anaphylactic) reaction to blood products. 4. Known history of intolerance to any of the components of the investigational product (IP). 5. Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception. 6. Previously enrolled in a clinical trial with FS Grifols. 7. Currently participating, or during the study is planned to participate, in any other investigational device or medicinal product study without prior and explicit approval from the sponsor. Intra-operative: 8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and 10) cannot be identified intra-operatively by the investigator (the surgeon). 9. TBS has Grade 3 (severe) bleeding according to the investigator's (the surgeon's) judgment that cannot be controlled with conventional surgical techniques to Grade 1 or Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale. 10. TBS is in an actively infected surgical field. 11. Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure. 12. Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | MHAT City clinic - Sveti Georgi | Montana | |
| Bulgaria | UMHAT Dr. Georgi Stranski | Pleven | |
| Bulgaria | UMHAT Sveti Georgi | Plovdiv | |
| Bulgaria | UMHAT Kanev | Ruse | |
| Bulgaria | UMHATEM N.I.Pirogov | Sofia | |
| Bulgaria | UMHAT Prof. Dr. Stoyan Kirkovich | Stara Zagora | |
| Canada | British Columbia's Children's Hospital | Vancouver | |
| France | Hôpitaux Pédiatriques de Nice CHU-Lenval | Nice | |
| France | Hôpital Armand Trousseau - APHP | Paris | |
| Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | |
| Hungary | Heim Pál Pediatric Hospital | Budapest | |
| Hungary | Semmelweis University, 2nd Dpt of Paediatrics | Budapest | |
| Hungary | University of Debrecen Clinical Center, Pediatric Clinic No. I. | Debrecen | |
| Hungary | Petz Aladár County Teaching Hospital, Department of Pediatric Surgery | Gyor | |
| Hungary | University of Pécs Clinical Centre, Pediatric Clinic | Pécs | |
| Romania | Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie" | Bucarest | |
| Romania | Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu" | Bucharest | |
| Romania | Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca | Cluj-Napoca | |
| Romania | Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria" | Iasi | |
| Romania | Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" | Timisoara | |
| Serbia | Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic" | Belgrade | |
| Serbia | University Children' s Hospital | Belgrade | |
| Serbia | Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics | Nis | |
| Serbia | Insititute for Health Protection of Children and Youth | Novi Sad | |
| Sweden | Karolinska Universitetssjukhuset | Huddinge | Stockholm |
| United Kingdom | Birmingham Children's Hospital NHS Foundation Trust | Birmingham | |
| United Kingdom | Clesea & Westmisnter Hospital | London | |
| United Kingdom | Southampton Children's Hospital | Southampton | |
| United States | The Urological Institute of Northeastern New York | Albany | New York |
| United States | MUSC Health-Children's Hospital | Charleston | South Carolina |
| United States | Lurie Childrens Hospital of Chicago | Chicago | Illinois |
| United States | Children's Medical Center Dallas | Dallas | Texas |
| United States | El Paso Childrens Hospital | El Paso | Texas |
| United States | Memorial Hermann Memorial City | Houston | Texas |
| United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
| United States | University of Michigan | Michigan Center | Michigan |
| United States | Columbia Medical Center | New York | New York |
| United States | St. Christophers Hospital | Philadelphia | Pennsylvania |
| United States | Carilion Children's Pediatric Surgery | Roanoke | Virginia |
| United States | University of Utah | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Grifols, S.A. |
United States, Bulgaria, Canada, France, Germany, Hungary, Romania, Serbia, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4) | Hemostasis is defined as Grade 0 bleeding per 5-point validated bleeding severity scale (0=no bleeding and 4=Unidentified or inaccessible spurting or gush) at the target bleeding site (TBS) according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. | From start of treatment until 4 minutes after treatment start (Day 1) | |
| Secondary | Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7) | Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T7 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure. | From start of treatment to 7 minutes after start of treatment (Day 1) | |
| Secondary | Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10) | Hemostasis is defined as Grade 0 bleeding at the TBS according to the investigator's (surgeon's) judgment, so that the surgical closure of the exposed field could begin. The cumulative percentage of participants achieving hemostasis at the TBS by the time points of T10 defined as an absence/cessation of bleeding (Grade 0) at the TBS by that time point without occurrence of rebleeding, Grade 3 or Grade 4 bleeding, use of alternative hemostatic treatment, and reapplication of study treatment after T4 and until TClosure. | From start of treatment to 10 minutes after start of treatment (Day 1) | |
| Secondary | Percentage of Participants With Treatment Failures | Participants were considered treatment failures if there is a. persistent bleeding at the TBS beyond T4 b. Grade 3 or Grade 4 breakthrough bleeding from the TBS that jeopardizes participant safety according to the investigator's judgment at any moment during the 10-minute observational period and until TClosure c. Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure, or use of study treatment at the TBS beyond T4 and until TClosure d. Rebleeding (Grade =1) at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure. | From start of treatment to 10 minutes after start of treatment and until the time of completion of surgical closure (Day 1) |