Trial Outcomes & Findings for Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery (NCT NCT02063035)
NCT ID: NCT02063035
Last Updated: 2017-06-08
Results Overview
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
17
|
|
Overall Study
COMPLETED
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=12 Participants
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=17 Participants
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
69 years
n=99 Participants
|
66 years
n=107 Participants
|
68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgeryPopulation: Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
Outcome measures
| Measure |
Tranexamic Acid
n=11 Participants
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=15 Participants
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
|
-3.2 grams per deciliter (g/dL)
Interval -4.6 to -2.4
|
-4.6 grams per deciliter (g/dL)
Interval -5.3 to -4.1
|
SECONDARY outcome
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 5 daysBlood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.
Outcome measures
| Measure |
Tranexamic Acid
n=12 Participants
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=17 Participants
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Blood Loss Volume Following Surgery
|
534 mL
Interval 260.0 to 705.0
|
530 mL
Interval 320.0 to 795.0
|
SECONDARY outcome
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeksThe number of days the participants stayed in the hospital after surgery was recorded.
Outcome measures
| Measure |
Tranexamic Acid
n=12 Participants
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=17 Participants
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Hospital Length of Stay in Days
|
5 days
Interval 4.0 to 8.0
|
6 days
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 5 daysAll units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.
Outcome measures
| Measure |
Tranexamic Acid
n=12 Participants
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=17 Participants
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Post-operative Blood Transfusions During Hospitalization
|
0 units of blood
Interval 0.0 to 1.0
|
0 units of blood
Interval 0.0 to 1.0
|
Adverse Events
Tranexamic Acid
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tranexamic Acid
n=12 participants at risk
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
Placebo
n=17 participants at risk
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
|
|---|---|---|
|
Cardiac disorders
Myocardial infaction
|
8.3%
1/12 • Number of events 1 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
0.00%
0/17 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
|
Surgical and medical procedures
Postoperative wound infection
|
8.3%
1/12 • Number of events 1 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
5.9%
1/17 • Number of events 1 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
|
Surgical and medical procedures
Postoperative wound infection after release from hospital
|
8.3%
1/12 • Number of events 1 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
0.00%
0/17 • From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kirkham B. Wood
Massachusetts General Hospital, Boston, MA, USA
Phone: 617-726-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place