TissueLink Study During Multi-Level Spine Surgery
Completed · Phase 4
Conditions studied: Low Back Pain
In brief
The overall objective of the investigators research is to test the clinical efficacy of the TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin loss intraoperatively. This is a prospective, randomized investigation that will be performed at Duke University Medical Center (DUMC). The overall goal of this study is to evaluate the efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss preoperatively, intraoperatively and postoperatively for patients undergoing multilevel elective spinal surgery. Not greater than eighty patients scheduled for elective, multi-level decompression and fusion spinal surgery with Dr. William Richardson will be randomized into two groups. Unipolar electrocautery will be used for intraoperative coagulation in one group and the Tissuelink device plus Unipolar electrocautery in the other. These are frequently performed cases with significant blood loss but otherwise low morbidity/mortality that would benefit from more effective intraoperative coagulation.
Key facts
- Study ID
- NCT01300559
- Run by
- Duke University
- People needed
- 60
- Starts
- 2006-04-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 18 years and older
- Sex: Both males and females will be included
- Patient has a Body Mass Index (BMI) <40
- Patient is willing and able to cooperate
- Patient is in stable health and cleared for surgery
- Patient is a candidate for elective multilevel posterior lumbar compression and fusion spinal surgery at least two or greater lumbar level involvement
- Patient has completed the Informed Consent Form
You may not qualify if…
- Patient is unable or unwilling to comply with the entire study protocol
- Patient has a previously diagnosed coagulopathy
- Patient has preoperative hemoglobin <11 g/dL
- Patient has a Prothrombin Time and International Normalized Ratio (PT/INR) >1.3
- Patient has a Partial Thromboplastin Time (PTT) >40
- Patient has a platelet count <100k
- Patients will also be excluded if taking non-aspirin medications producing a bleeding diathesis undetectable by screening labs such as clopidogrel or ticlopidine within seven days of surgery or valproic acid (associated with thrombocytopenia)
- Trauma patients are excluded
- Patient is a poor compliance risk, i.e., history of ethanol, drug abuse
- Severe cardiac disorder requiring special fluid management protocols
- Patients with acute myocardial infarction and/or acute angina
- Patient is on Plavix or other long term anti-coagulation including aspirin (ASA) or other nonsteroidal antiinflammatory drugs (NSAIDs) may be included provided their medications are discontinued a minimum of 7 days prior to surgery
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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