- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509208
A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kristiansund, Norway
- Helse Møre og Romsdal HF, Kristiansund sjukehus
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Ålesund, Norway
- Helse Møre og Romsdal HF, Ålesund sjukehus
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Aberdeen, United Kingdom, AB15 6LS
- Aberdeen Royal Infirmary
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Cottingham, United Kingdom, HU16 5JQ
- Castle Hill Hospital
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Newcastle upon Tyne, United Kingdom, NE1 4LP
- Royal Victoria Infirmary
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Manchester
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Salford, Manchester, United Kingdom, M68HD
- Salford Royal Infirmary
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Shropshire
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Oswestry, Shropshire, United Kingdom, SY10 7AG
- Jones & Hunt Orthopaedic Hospital
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Yorkshire
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Doncaster, Yorkshire, United Kingdom, DN2 5LT
- Doncaster Royal Infirmary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SurgiClot
All qualified subjects will be treated with the SurgiClot haemostatic dressing
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haemostatic dressing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes
Time Frame: 3 minutes
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3 minutes
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Incidence of device-related adverse events
Time Frame: 6 weeks
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of patients needing a repeat application of the dressing
Time Frame: intra-operative
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intra-operative
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Proportion of repeat applications that achieve haemostasis
Time Frame: intra-operative
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intra-operative
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Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT)
Time Frame: 6 weeks
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6 weeks
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Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT)
Time Frame: 6 weeks
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6 weeks
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Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR)
Time Frame: 6 weeks
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6 weeks
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Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen
Time Frame: 6 weeks
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6 weeks
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Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire
Time Frame: intra-operative
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intra-operative
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Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire
Time Frame: intra-operative
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intra-operative
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Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire
Time Frame: intra-operative
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intra-operative
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Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire
Time Frame: intra-operative
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intra-operative
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Mean volume of blood loss through the standard of care of the hospital
Time Frame: 24 hours
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niall Craig, MD, Aberdeen Royal Infirmary
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STM-UK-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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