Clinical trial NCT01300559: TissueLink Study During Multi-Level Spine Surgery
Official title: Efficacy of the TissueLink Coagulation System in Reducing Hemoglobin Loss During Multi-Level Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: efficacy
hemoglobin
spine
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Salient Surgical Technologies
First posted: 2011-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Very little research exists in the use of TissueLink HemoSealing device in spinal surgery. One retrospective study by Snyder et al evaluated hemostatic efficacy of this technology in children undergoing surgery for spinal fusion and instrumentation. Although the study reported no statistically significant difference in transfusion rates, there was a reduction in amount of blood transfused and operative time which was attributed to hemostatic efficacy in comparison with conventional wound management during surgery. The surgeons also reported a clearer operative field, improving visualization during surgery. Finally, the reduction in operative time which they suggested might be due to the use of this new device may reduce other complications by diminishing overall anesthesia exposure and blood product transfusions. From this initial retrospective study, the authors concluded that the use of the TissueLink HemoSealing device in spine surgery may be an effective tool in control of intra- and post-operative blood loss and may significantly reduce blood related and operative complications. More rigorous research needs to be done to evaluate the efficacy of the TissueLink HemoSealing device in hemostasis in the area of spine surgery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin Measurement g/dl
timeFrame: At the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Steven E Hill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: William J Richardson, MD
role: STUDY_CHAIR
References:
citation: Hill SE, Broomer B, Stover J, White W, Richardson W. Bipolar tissue sealant device decreases hemoglobin loss in multilevel spine surgery. Transfusion. 2012 Dec;52(12):2594-9. doi: 10.1111/j.1537-2995.2012.03649.x. Epub 2012 Apr 15.