Cancellous Bone Bleeding
Conditions
Keywords
iliac crest bone graft, ICBG, pelvic osteotomy, spinal fusion, hemostasis, haemostasis, hemostatic, haemostatic, dextran, SurgiClot, cancellous bone bleeding
Brief summary
The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.
Detailed description
Patients who require surgery for iliac crest bone graft (ICBG), pelvic osteotomy or spinal fusion will be screened for this multicenter, prospective, non-randomized, open-label study. All qualified subjects will be treated with the SurgiClot® haemostatic dressing (a completely soluble dressing consisting of solid nanofibers of electrospun dextran with embedded lyophilized human fibrinogen and thrombin proteins). The safety and performance of the SurgiClot dressing will be evaluated in up to 40 subjects enrolled in Europe. Subjects will be followed for six weeks after the surgery.
Interventions
DEVICESurgiClot haemostatic dressing
haemostatic dressing
Sponsors
St. Teresa Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a planned elective orthopaedic or spinal surgical procedure. Spinal surgery can be the entire spine although it should be confined to one or two-level fusions e.g. one or two level cervical, or thoracic or lumbar. * Patient has an intraoperative bleeding site involving cancellous bone that the surgeon would typically treat with another topical haemostatic agent to control the bleeding. * Patient has normal liver function * The subject is willing and able to comply with the requirements of the study protocol, including the six weeks follow-up evaluation.
Exclusion criteria
* Is unable or unwilling to return for the follow-up visit. * The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure. * Active infection at the surgical site. * Pregnancy, as determined by urine pregnancy test, or breast feeding. * Pre-operative platelet count \< 150,000, INR \> 1.3, and/or APTT \> 32.4. * Pre-operative anaemia (Hb \< 110 g/L in females, Hb \< 120 g/L in males). * Use of anticoagulant therapy (e.g., coumadin, heparin, clopidogrel), non-steroidal anti-inflammatory medications or fish oil supplements within 7 days of the surgery except for aspirin. (maximum dose 150 mg per day) * Patient with a blood dyscrasia. * Presence of a spinal tumour, intradural pathology, or prior spinal fusion surgery at the same target site. * Participation in another clinical trial with an investigational drug or device within the past 30 days. * Known allergy to human fibrinogen, human thrombin, or porcine-derived products. * Compromised immune system. * The use of a haemostatic agent is contraindicated for the subject. * Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment. * Haematological disease (thromboembolic events, haemoglobinopathy, coagulopathy or haemolytic disease) * Significant co-morbidities: Previous myocardial infarction (MI); severe ischemic heart disease (New York Heart Association Class III, IV); severe pulmonary disease; chronic renal failure; hepatic failure; uncontrolled hypertension. * Subject is unwilling to receive blood products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes | 3 minutes |
| Incidence of device-related adverse events | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients needing a repeat application of the dressing | intra-operative |
| Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT) | 6 weeks |
| Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR) | 6 weeks |
| Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen | 6 weeks |
| Proportion of repeat applications that achieve haemostasis | intra-operative |
| Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire | intra-operative |
| Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire | intra-operative |
| Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire | intra-operative |
| Mean volume of blood loss through the standard of care of the hospital | 24 hours |
| Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire | intra-operative |
| Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT) | 6 weeks |
Countries
Norway, United Kingdom
Outcome results
None listed