Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery
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|ClinicalTrials.gov Identifier: NCT02314988|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2014
Last Update Posted : March 28, 2019
This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements.
The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients following high energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or ligamentous injury with resultant instability requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2 week, 16 week, 1 year, and 2 year) time points.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Injuries Spinal Deformity||Drug: Tranexamic Acid Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Topical Application of Tranexamic Acid to Reduce Blood Loss During Complex Combat-related Spine Trauma Surgery|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Active Comparator: Intervention
Subjects will receive tranexamic acid on the surgical wound.
Drug: Tranexamic Acid
3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.
TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.
Placebo Comparator: Placebo control
Subjects will receive placebo (saline solution) on the surgical wound.
Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.
The placebo solution will be 100 mL of sterile normal saline.
Other Name: Saline Solution
- Maximal drop in systemic hemoglobin concentration during the postoperative period [ Time Frame: Patients will be followed through postoperative day 4 ]
- Reduction in the rate of surgical site infections [ Time Frame: Duration of the hospital stay (an average of 2 weeks), first postoperative wound check visit ]Defined by decreasing the allogenic transfusion rate (an independent risk factor for surgical site infections) as well as by decreasing the formation of postoperative hematoma (a nidus for infection).
- Number of complications [ Time Frame: Up to postoperative day 4 ]Defined as thromboembolic event, including deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Systemic absorption of locally applied drug [ Time Frame: Baseline (pre-surgery), immediately after administration of the topical agent, 1 hour after administration ]
- Patient assessed health-related quality of life score [ Time Frame: Up to 2 years postoperation ]This will be determined by a questionnaire/score
- Difference in costs for hospital stay between using tranexamic acid and placebo [ Time Frame: Duration of the hospital stay (an average of 2 weeks) ]Patient cost information will be gathered for the duration of the hospital stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314988
|Contact: Ronald A Lehman, MDfirstname.lastname@example.org|
|United States, Maryland|
|Walter Reed National Medical Center||Not yet recruiting|
|Bethesda, Maryland, United States, 20889|
|United States, New York|
|NYP/The Allen Hospital - CUMC||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Ronald A Lehman, MD email@example.com|
|Principal Investigator: Ronald A Lehman, MD|
|United States, Pennsylvania|
|Thomas Jefferson University Medical Center||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Ronald A Lehman, MD||Columbia University|