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Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer

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ClinicalTrials.gov Identifier: NCT02427711
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Christian Skovgaard Nielsen, Hvidovre University Hospital

Brief Summary:
To investigate if the use of a bipolar sealer for skin and capsula incision results in decreased total blood loss and/or less blood transfusion in non-septic knee arthroplasty.

Condition or disease Intervention/treatment Phase
Total Blood Loss Device: Bipolar sealer Not Applicable

Detailed Description:

In patients undergoing primary total knee arthroplasty, perioperative anemia is highly prevalent. In a systematic review, preoperative anemia was found in 24 +/- 9% and postoperative anemia in 51% +/- 10%. Perioperative anemia was associated with a blood transfusion rate of 45 +/- 25%, postoperative infections, poorer physical functioning and recovery, and increased length of hospital stay (LOS) and mortality. Although the best transfusion trigger in elective patients remains unknown, restrictive transfusion protocols are recommended and avoidance of blood transfusion if possible.

The only non-systemic modality capable of reducing blood loss before it occurs is a bipolar sealer (Aquamantys). By pre-incisional treatment of the soft tissue, bleeding (and potentially total blood loss and transfusion) is reduced without tissue charring.

Previously studies on the use of Aquamantys in primary knee arthroplasty have had various outcomes, the most recent being negative while the former 3 were positive regarding reduction in blood loss, drop in hgb and transfusions. No published date exist on potential outcomes in revision knee arthroplasty where blood loss and transfusion needs exceeds that of primary total knee arthroplasty by far. Aquamantys hence would theoretically benefit the most in a revision setting without the use of a tourniquet - and would be an interesting modality in modern contemporary fast-track revision if shown effective despite/on top of the use of additional blood saving modalities. The present study is therefore motivated by investigating this aspect.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduced Total Blood Loss and Blood Transfusion in Non-Septic Revision Knee Arthroplasty Using a Bipolar Sealer - A Prospective Cohort Study With Retrospective Controls
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bipolar sealer
Prospective use of bipolar sealer for skin and knee capsule incision revisions of non-septic knee arthroplasty.
Device: Bipolar sealer
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Other Name: Aquamantys

Placebo Comparator: Scalpel
Conventional surgical incision with scalpel - data extracted from a retrospective group.
Device: Bipolar sealer
Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
Other Name: Aquamantys




Primary Outcome Measures :
  1. Estimated blood loss [ Time Frame: 2nd postoperative morning ]

Secondary Outcome Measures :
  1. Blood loss [ Time Frame: 1st. postoperative morning ]
  2. Blood transfusion [ Time Frame: while hospitalized expected 5 days. ]
  3. Readmission [ Time Frame: 90 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Non septic knee-arthroplasty revision.
  • Musk speak and understand Danish

Exclusion Criteria:

  • Age below 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427711


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Christian Skovgaard Nielsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02427711    
Other Study ID Numbers: HVH-2013-037
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: April 2015
Keywords provided by Christian Skovgaard Nielsen, Hvidovre University Hospital:
Reduction of blood loss for revisions of knee arthroplasty
blood transfusions
Readmission
Bipolar sealer
Additional relevant MeSH terms:
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Hemorrhage
Exsanguination
Pathologic Processes