Clinical trial NCT02509208: A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
Official title: A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancellous Bone Bleeding
Keywords: iliac crest bone graft
ICBG
pelvic osteotomy
spinal fusion
hemostasis
haemostasis
hemostatic
haemostatic
dextran
SurgiClot
cancellous bone bleeding
Lead sponsor: St. Teresa Medical
Sponsor class: INDUSTRY
First posted: 2015-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes
timeFrame: 3 minutes
measure: Incidence of device-related adverse events
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of patients needing a repeat application of the dressing
timeFrame: intra-operative
measure: Proportion of repeat applications that achieve haemostasis
timeFrame: intra-operative
measure: Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT)
timeFrame: 6 weeks
measure: Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT)
timeFrame: 6 weeks
measure: Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR)
timeFrame: 6 weeks
measure: Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen
timeFrame: 6 weeks
measure: Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire
timeFrame: intra-operative
measure: Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire
timeFrame: intra-operative
measure: Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire
timeFrame: intra-operative
measure: Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire
timeFrame: intra-operative
measure: Mean volume of blood loss through the standard of care of the hospital
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Helse Møre og Romsdal HF, Kristiansund sjukehus
city: Ålesund
country: Norway
facility: Helse Møre og Romsdal HF, Ålesund sjukehus
city: Salford
country: United Kingdom
facility: Salford Royal Infirmary
state: Manchester
city: Oswestry
country: United Kingdom
facility: Jones & Hunt Orthopaedic Hospital
state: Shropshire
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: Yorkshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Aberdeen Royal Infirmary
name: Niall Craig, MD
role: PRINCIPAL_INVESTIGATOR
References: