A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding

Conditions
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Cancellous Bone Bleeding

Intervention / Treatment
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* Device: SurgiClot haemostatic dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurgiClot<br>All qualified subjects will be treated with the SurgiClot haemostatic dressing | Device: SurgiClot haemostatic dressing<br>* haemostatic dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients needing a repeat application of the dressing |  | intra-operative | 
| Proportion of repeat applications that achieve haemostasis |  | intra-operative | 
| Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT) |  | 6 weeks | 
| 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 | 
| Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dextran, iliac crest bone graft, ICBG, pelvic osteotomy, spinal fusion, hemostasis, haemostasis, hemostatic, haemostatic, SurgiClot, cancellous bone bleeding