Cancellous Bone BleedingNCT02509208
A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
A study testing SurgiClot haemostatic dressing in people with Cancellous Bone Bleeding, run by St. Teresa Medical at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancellous Bone Bleeding
- What is being tested?
- SurgiClot haemostatic dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom6 sites
Aberdeen Royal Infirmary
Aberdeen, AB15 6LS
Castle Hill Hospital
Cottingham, HU16 5JQ
Doncaster Royal Infirmary
Doncaster, Yorkshire, DN2 5LT
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Jones & Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
Salford Royal Infirmary
Salford, Manchester, M68HD
Norway2 sites
Helse Møre og Romsdal HF, Ålesund sjukehus
Ålesund
Helse Møre og Romsdal HF, Kristiansund sjukehus
Kristiansund
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancellous Bone Bleeding
- Being tested
- SurgiClot haemostatic dressing
- Keywords
- iliac crest bone graft, ICBG, pelvic osteotomy, spinal fusion, hemostasis, haemostasis, hemostatic, haemostatic, dextran, SurgiClot, cancellous bone bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiClot haemostatic dressingDevice
haemostatic dressing
| Study group | Role | What they receive |
|---|---|---|
| SurgiClot | Experimental | All qualified subjects will be treated with the SurgiClot haemostatic dressing Receives: Device: SurgiClot haemostatic dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes
Measured: 3 minutes
Incidence of device-related adverse events
Measured: 6 weeks
Secondary outcomes (11)
Proportion of patients needing a repeat application of the dressing
Measured: intra-operative
Proportion of repeat applications that achieve haemostasis
Measured: intra-operative
Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT)
Measured: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT)
Measured: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR)
Measured: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen
Measured: 6 weeks
Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire
Measured: intra-operative
Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire
Measured: intra-operative
Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire
Measured: intra-operative
Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire
Measured: intra-operative
Mean volume of blood loss through the standard of care of the hospital
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancellous Bone BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Teresa Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niall Craig, MD, Principal investigator, Aberdeen Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509208
- Sponsor's protocol ID
- STM-UK-001
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
- ClinicalTrials.gov ID
- NCT02509208
- Acronym / sponsor ID
- STM-UK-001
- Conditions
- Cancellous Bone Bleeding
- Keywords
- iliac crest bone graft, ICBG, pelvic osteotomy, spinal fusion, hemostasis, haemostasis, hemostatic, haemostatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Teresa MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SurgiClot | Experimental | Device: SurgiClot haemostatic dressingAll qualified subjects will be treated with the SurgiClot haemostatic dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgiClot haemostatic dressinghaemostatic dressing | Device | SurgiClot |
Primary outcome
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes
Time frame: 3 minutes
Incidence of device-related adverse events
Time frame: 6 weeks
11 secondary outcomes
Proportion of patients needing a repeat application of the dressing
Time frame: intra-operative
Proportion of repeat applications that achieve haemostasis
Time frame: intra-operative
Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen
Time frame: 6 weeks
Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Mean volume of blood loss through the standard of care of the hospital
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Hemostasis, Surgical Blood Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall Craig, MD principal investigator
Aberdeen Royal Infirmary
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgiClot haemostatic dressing in people with Cancellous Bone Bleeding, run by St. Teresa Medical at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes (time frame: 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.