Albany Medical Center
Albany, New York, 12208, United States
NCT Number: NCT04312880
Tranexamic acid (TXA) is an agent that has been shown to be safe and effective to reduce blood loss in surgical procedures. The purpose of the study is to assess the effect of transexamic on elective decompressive lumbar spine surgery with and without fusion.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Albany, New York, 12208, United States
This will be a prospective randomized control, double-blinded investigation. The Investigators will recruit patients undergoing elective, primary, decompressive lumbar surgery via a posterior surgical approach of less than 3 levels. This includes patients undergoing decompressive lumbar laminectomies with or without fusion. Fusion may include posterior interbody and/or posterior lateral techniques with instrumentation.
There will be 3 treatment arms with the goal of 65 patients in each arm. Patients will be randomized pre-operatively and enrolled into the IV transexamic acid group (receiving intraoperative intravenous tranexamic acid infusion), or the topical transexamic acid group or the control/placebo group (receiving intraoperative intravenous saline). The Investigators expect the duration of each treatment group to be approximately 4-5 months. Therefore, the study should be completed within 1.5 years. The primary surgeon and anesthesia staff will not be blinded to the treatment arm due to the nature of the different administration routes, but post-operative nursing staff will be blinded to administration routes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV and topical form of TXA will be administered to patients in the respective groups.
Time frame: 48 hours postoperatively
Drains will be placed during surgery, this will be recorded by nursing staff on a regular schedule and we will assess the results as a surrogate for blood loss post operatively
Time frame: two days post operatively
Labs will be recorded each morning after the surgery, this includes hematocrit
Time frame: two days post operatively
Labs will be recorded each morning after the surgery, this includes hemoglobin
Time frame: 30 days post operatively
We will assess which treatment arms, if any had increased rate of Emergency department visits for any reason
Time frame: 30 days post operatively
We will assess which treatment arms, if any had increased rate of readmission to the hospital
Time frame: 30 days post opertively
We will assess is any treatment arm had an increased risk of PE
Time frame: 30 days post opertively
We will assess is any treatment arm had an increased risk of DVT
Albany Medical College
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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