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TissueLink Study During Multi-Level Spine Surgery

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tissuelink device

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring efficacy, hemoglobin, spine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

No treatment

Arm Description

Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.

Unipolar electrocautery without Tissuelink device will be used in this arm of the study.

Outcomes

Primary Outcome Measures

Hemoglobin Measurement g/dl

The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.

Secondary Outcome Measures

Full Information

NCT ID

NCT01300559

First Posted

February 3, 2011

Last Updated

January 3, 2013

Sponsor

Duke University

Collaborators

Salient Surgical Technologies

1. Study Identification

Unique Protocol Identification Number

NCT01300559

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Salient Surgical Technologies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

efficacy, hemoglobin, spine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.

Arm Title

No treatment

Arm Type

No Intervention

Arm Description

Unipolar electrocautery without Tissuelink device will be used in this arm of the study.

Intervention Type

Device

Intervention Name(s)

Tissuelink device

Other Intervention Name(s)

Aquamantys

Intervention Description

Tissuelink device plus Unipolar electrocautery

Primary Outcome Measure Information:

Title

Hemoglobin Measurement g/dl

Description

Time Frame

At the end of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven E Hill, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

William J Richardson, MD

Organizational Affiliation

Duke University

Official's Role

Study Chair

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22500572

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.

Results Reference

derived

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TissueLink Study During Multi-Level Spine Surgery

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