Paediatric patients undergoing abdominal or orthopedic surgery MedDRA version: 18.0 Level: PT Classification code 10067439 Term: Haemostasis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Colla di fibrina kedrion
Pharmaceutical Form: Powder and solvent for sealant
INN or Proposed INN: FIBRINOGENO UMANO LIOFILIZZATO
CAS Number: 9001-32-5
Current Sponsor code: E03FB0313
Oth
Sponsors
KEDRION S.P.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: . Use of other agents adhesives /sealants not provided for the Protocol; 2. Presence of conditions that, in the opinion of the investigator, may interfere with the evaluation of the objective of the study or participation in the study; 3. Previous exposure to products containing bovine aprotinin for less than 12 months (positive to bovine aprotinin antibodies ); 4. Known allergies to blood components; 5. Participation in another clinical trial in the month preceding the start of the study (in the last 30 days the subject has taken other investigational drugs); 6. Subjects who are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effective Primary Objectives: 1) To evaluate the efficacy of Kedrion fibrin glue used as an adjuvant in hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. The superiority of Kedrion Fibrin Glue to the standard treatment will be assessed using the Cochran-Mantel-Haenszel test, adjusting for age site and type of surgery. Safety Objectives Primary: 1) To Eealuate the Safety of kedrion Fibrin glue used as an adjuvant in hemostasis in pediatric patients undergoing abdominal or orthopedic surgery for the duration of the study.;Secondary Objective: Secondary efficacy objectives: 1) To evaluate the efficacy of Kedrion fibrin glue in the control of blood loss during the intra- and post-operative period in pediatric patients undergoing abdominal or orthopedic surgery.;Primary end point(s): Primary Efficacy Endpoints 1) Percentage of patients achieving complete hemostasis within 4 minutes from the end of the application of Kedrion fibrin glue. The application of Kedrion Fibrin Glue and the following measuring 4 minutes begins when the patient has reached a sufficient hemostasis (scale score 3) at the surgical site. The measurement of timewill have to start from this point in the case of control, and at the end of the application of Kedrion fibrin glue in cases treated with Glue, and will last for 4 minutes. Hemostasis will be considered satisfactory if, during the four minutes, you will not require any additional surgery to control bleeding (stitches, bleeding, prolonged compression, application of topical agents). If the patient in 4 minutes will not achieve hemostasis, will be considered as a negative result. Primary endpoints of safety 1. Percentage of subjects who develop adverse events associated with treatment (Kedrion Fibrin Glue Treatment or Standard) until the Follow-up visit. 2. Percentage of subjects who develop allergic reactions and hypersensitivity associated with the application of Kedrion fibrin glue. 3. Perc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints 1) Amount of bleeding (in ml), intra-operative and post-operative. 2) Measurement of CBC, Hb, Hct at 3, 6, 12 ± 1 and 24 ± 1 hours after surgery. 3) Amount of transfusion of Fresh Frozen Plasma (FFP), red blood cells and platelets during and after surgery. The need for transfusion should be detailed in the CRF reporting in addition to the minimum that is Hb Hct (respectively = 8 g / dL and = 24%), other specific patient conditions that support decision to carry out the transfusion in each case;Timepoint(s) of evaluation of this end point: The secondary endpoints of safety will be measured at visit 1 (randomization / surgery, Day 1), time 2 (post-operative period, days 1-2). | — |
Countries
Italy
Contacts
Public ContactMedical & Scientific Information
Kedrion S.P.A
Outcome results
None listed