Phase 4 N=60 Randomized Double-blind Treatment

TissueLink Study During Multi-Level Spine Surgery

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT01300559 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Feb 2013

Primary outcome: Primary: Hemoglobin Measurement g/dl — 66.2; 102.4 hemoglobin g/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tissuelink device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin Measurement g/dl	66.2; 102.4	—

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.

Eligibility Criteria

Inclusion Criteria

Age: 18 years and older
Sex: Both males and females will be included
Patient has a Body Mass Index (BMI) 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

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Data sourced from ClinicalTrials.gov (NCT01300559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.