Trial Outcomes & Findings for Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery (NCT NCT03425799)
NCT ID: NCT03425799
Last Updated: 2021-06-21
Results Overview
The Total Blood Loss will be estimated based on the hemoglobin content of the blood prior to surgery (mg/dL) and at each of the desired post-surgery time-points (mg/dL). Blood samples for hemoglobin measurement will be collected prior to start of procedure, at the end of the procedure, at 24 h, and every 24 h thereafter until discharge and removal two subfascial drains.
TERMINATED
PHASE3
5 participants
From time of surgery until discharge
2021-06-21
Participant Flow
Study terminated due to low recruitment
Study terminated due to low recruitment
Participant milestones
| Measure |
Tranexamic Acid 10 mg/mL
Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg
Tranexamic Acid: Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
|
Placebo
Placebo (0.9% Sodium Chloride) infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg
Placebo Intravenous Infusion Bags, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
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|---|---|---|
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Overall Study
STARTED
|
0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: From time of surgery until dischargePopulation: Data were not collected
The Total Blood Loss will be estimated based on the hemoglobin content of the blood prior to surgery (mg/dL) and at each of the desired post-surgery time-points (mg/dL). Blood samples for hemoglobin measurement will be collected prior to start of procedure, at the end of the procedure, at 24 h, and every 24 h thereafter until discharge and removal two subfascial drains.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From time of surgery until dischargePopulation: Study was terminated due to low recruitment. Data were not collected.
Number of Units of autologous transfusion and allogenic transfusion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of surgery up to 24 hours after surgeryPopulation: Total number of patients recruited and treated was 5 patients. No analyses were performed due to early termination of the study due to low recruitment.
Estimated as 3x cell saver
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until dischargePopulation: Total number of patients recruited and treated was 5 patients. No analyses were performed due to early termination of the study due to low recruitment.
Number of patients with symptomatic anemia precipitated transfusion in each group
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Total number of patients recruited and treated was 5 patients. No analyses were performed due to early termination of the study due to low recruitment.
Number of patients with adverse events related to tranexamic acid in each group
Outcome measures
Outcome data not reported
Adverse Events
Sodium Chloride 0.9%
Tranexamic Acid 10 mg/mL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aruna Koganti, VP Clinical Programs
Exela Pharma Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place