Trial Outcomes & Findings for Tranexamic Acid Dosing in Adult Spinal Deformity Surgery (NCT NCT02053363)
NCT ID: NCT02053363
Last Updated: 2022-06-08
Results Overview
To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
64 participants
Primary outcome timeframe
This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.
Results posted on
2022-06-08
Participant Flow
12 Patients consented to participation but withdrew prior to randomization and treatment assignment. Patients either elected not to proceed with the study, did not have surgery, or the proposed surgeries were changed and they were no longer eligible for participation.
Participant milestones
| Measure |
High Dose/Study Group
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose/Study Group
n=25 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=25 Participants
|
18 Participants
n=27 Participants
|
34 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=25 Participants
|
9 Participants
n=27 Participants
|
18 Participants
n=52 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.6 • n=25 Participants
|
56.7 years
STANDARD_DEVIATION 14.3 • n=27 Participants
|
58.3 years
STANDARD_DEVIATION 12.1 • n=52 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=25 Participants
|
23 Participants
n=27 Participants
|
37 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=25 Participants
|
4 Participants
n=27 Participants
|
15 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
27 participants
n=27 Participants
|
52 participants
n=52 Participants
|
PRIMARY outcome
Timeframe: This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.
Outcome measures
| Measure |
High Dose/Study Group
n=25 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Blood Loss
|
2046 mL
Standard Deviation 1104
|
1596 mL
Standard Deviation 933
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days.To compare the mean volume (mL) of packed red blood cell (PRBC) transfusions given to the two groups. Volumes of RBC vary from bag to bag and real volumes will be recorded as provided by the blood bank.
Outcome measures
| Measure |
High Dose/Study Group
n=25 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Red Blood Cell Transfusions
|
1259 mL
Standard Deviation 868
|
935 mL
Standard Deviation 630
|
SECONDARY outcome
Timeframe: Perioperative complications were defined as complications occurring within 90 days of surgery.Population: All patients achieved 90 day followup
To compare the rates of intraoperative complications and 90 day complications observed in the two groups.
Outcome measures
| Measure |
High Dose/Study Group
n=25 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 Participants
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Number of Patients Sustaining Intraoperative or 90 Day Complications
|
2 Participants
|
3 Participants
|
Adverse Events
High Dose/Study Group
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard of Care/Control
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose/Study Group
n=25 participants at risk
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 participants at risk
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • Up to three months after surgery
|
0.00%
0/27 • Up to three months after surgery
|
|
Blood and lymphatic system disorders
Venothromboembolic Event
|
0.00%
0/25 • Up to three months after surgery
|
7.4%
2/27 • Number of events 2 • Up to three months after surgery
|
|
Cardiac disorders
Arrhythmia
|
4.0%
1/25 • Number of events 1 • Up to three months after surgery
|
3.7%
1/27 • Number of events 1 • Up to three months after surgery
|
Other adverse events
| Measure |
High Dose/Study Group
n=25 participants at risk
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
Standard of Care/Control
n=27 participants at risk
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
Tranexamic Acid (Cyklokapron)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Infection
|
12.0%
3/25 • Number of events 3 • Up to three months after surgery
|
7.4%
2/27 • Number of events 2 • Up to three months after surgery
|
|
Nervous system disorders
Delirium
|
0.00%
0/25 • Up to three months after surgery
|
3.7%
1/27 • Number of events 1 • Up to three months after surgery
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/25 • Up to three months after surgery
|
3.7%
1/27 • Number of events 1 • Up to three months after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place