A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bl… (NCT02509208) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
Norway, United Kingdom30 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dev…
What they're measuring
1
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes