STOP IT: STUDY TO ASSESS THE SAFETY AND PERFORMANCE OF SURGICLOTÂ® IN THE TREATMENT OF CANCELLOUS BONE BLEEDING - STOP IT

St Teresa Medical Inc0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) 18 years of age or older.
•2) Undergoing a planned elective iliac crest bone graft, pelvic osteotomy or spinal fusion. Spinal surgery can be the entire spine although the spinal fusion should be confined to one or two-levels e.g. one or two level cervical, thoracic or lumbar.
•3) Likely to have an intraoperative surgical site involving cancellous bone that the surgeon would typically treat with another topical haemostatic agent to control the bleeding.
•4) Willing to provide informed consent and to comply with the requirements of the study protocol, including the six weeks follow-up evaluation.
•5) Pre-operative platelet count > 150,000, INR < 1.3 and aPTT < 44.0 sec.
•6) Pre-operative Haemoglobin > 12 gm/dL in females or > 13 gm/dL in males.

•1) Surgery at the intended application site <= 6 months before the current surgical procedure.
•2) Active infection at the surgical site.
•3) Pregnancy, as determined by urine pregnancy test, or breast feeding.
•4) Abnormal liver function.
•5) 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).
•6) Blood dyscrasia.
•7) Presence of a spinal tumour, intradural pathology, or prior spinal fusion surgery at the same target site.
•8) Participation in another clinical study with an investigational product within the past 30 days.
•9) Known allergy to human fibrinogen or human thrombin.
•10) Compromised immune system.
•11) Contraindicated use of a haemostatic agent.
•12) Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment.
•13) Haematological disease (thromboembolic events, haemoglobinopathy, coagulopathy or haemolytic disease).
•14) Significant co-morbidities: previous MI; severe ischemic heart disease (NYHA Class III, IV); severe pulmonary disease; chronic renal failure; hepatic failure; uncontrolled hypertension.
•15) Unwilling to receive blood products.

发起方

St Teresa Medical Inc