Health Condition 1: null- Patients who are prone to cancellous bone bleeding during Neurosurgery (Iliac Crest Bone Grafting, Pelvic Osteotomy and Spinal Fusion)
Conditions
Interventions
Intervention1: SURGICLOT®: Treatment of Cancellous bone bleeding using SURGICLOT® device in neurosurgery, including Iliac crest bone grafting, Pelvic Osteotomy and Spinal Fusion.
Intervention2: SURG
Sponsors
St Teresa Medical Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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 6) Pre-operative Haemoglobin > 12 gm/dL in females or > 13 gm/dL in males.
Exclusion criteria
Exclusion criteria: 1) Surgery at the intended application site 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects that achieve controlled haemostasis at target bleeding site at 3 minutes. â??Controlled haemostasisâ?? is when bleeding from the exposed bone surfaces is either insignificant and does not require further treatment with any haemostatic action or stopped completely.Timepoint: 3 Minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess the need for repeat application of the dressing and determine if the repeat application results in controlled bleeding. 2. Negative immunogenicity response as determined by assay of coagulation factors (PT, aPTT, INR and fibrinogen levels). 3. Assess dressing characteristics including: dissolvability, ease of preparation, conformability and ease of use via a handling questionnaire. 4. Collect information on blood loss through the standard of care of the hospital.Timepoint: 6 Weeks | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
STAR Hospitals
Outcome results
None listed