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

The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.

Study Overview

• Status: Completed
• Conditions: Cancellous Bone Bleeding
• Intervention / Treatment: Device: SurgiClot haemostatic dressing

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Helse Møre og Romsdal HF, Kristiansund sjukehus
  • Ålesund, Norway
    • Helse Møre og Romsdal HF, Ålesund sjukehus
• United Kingdom
  • Aberdeen, United Kingdom, AB15 6LS
    • Aberdeen Royal Infirmary
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Manchester
    • Salford, Manchester, United Kingdom, M68HD
      • Salford Royal Infirmary
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • Jones & Hunt Orthopaedic Hospital
  • Yorkshire
    • Doncaster, Yorkshire, United Kingdom, DN2 5LT
      • Doncaster Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SurgiClot; All qualified subjects will be treated with the SurgiClot haemostatic dressing	Device: SurgiClot haemostatic dressing; haemostatic dressing

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	3 minutes
Incidence of device-related adverse events	6 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: St. Teresa Medical
• Investigators: Principal Investigator: Niall Craig, MD, Aberdeen Royal Infirmary

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: haemostasis; hemostasis; spinal fusion; iliac crest bone graft; ICBG; pelvic osteotomy; hemostatic; haemostatic; dextran; SurgiClot; cancellous bone bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: STM-UK-001