Trial Outcomes & Findings for Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP) (NCT NCT05082142)

NCT ID: NCT05082142

Last Updated: 2024-05-16

Results Overview

Number of participants who are discharged on the same day and have same-day catheter removal.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 110 participants
• Primary outcome timeframe: Day 0-1
• Results posted on: 2024-05-16

Participant Flow

Participant milestones

Measure	TXA Intraoperatively Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively Patients will not receive intraoperative TXA during the HoLEP procedure.
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
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	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.	Total n=110 Participants Total of all reporting groups
Age, Continuous	69.1 years n=55 Participants	69.7 years n=55 Participants	69.4 years n=110 Participants
Sex: Female, Male Female	0 Participants n=55 Participants	0 Participants n=55 Participants	0 Participants n=110 Participants
Sex: Female, Male Male	55 Participants n=55 Participants	55 Participants n=55 Participants	110 Participants n=110 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	55 participants n=55 Participants	55 participants n=55 Participants	110 participants n=110 Participants
Pre-op Prostate size, continious	114 cc n=55 Participants	105.5 cc n=55 Participants	109.8 cc n=110 Participants

PRIMARY outcome

Timeframe: Day 0-1

Number of participants who are discharged on the same day and have same-day catheter removal.

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Same-day Discharge Rate	50 Participants	49 Participants

PRIMARY outcome

Timeframe: Day 0-1

Post-operative to discharge home

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Length of Stay	170 minutes Interval 127.0 to 243.0	187 minutes Interval 141.0 to 320.0

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Same Day Discharge	51 Participants	49 Participants

SECONDARY outcome

Timeframe: 12 weeks

Participants who have bleeding complications (defined as unplanned ED visit/clinic/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion). This will be assessed by a weekly survey distributed to participants for 12 weeks.

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Number of Participants With Bleeding Complications	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 12 weeks

Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 0

Operative times during HoLEP procedure.

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Operative Times	58 minutes Interval 46.5 to 75.5	53 minutes Interval 43.0 to 70.5

SECONDARY outcome

Timeframe: 12 weeks

Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).

Outcome measures

Measure	TXA Intraoperatively n=55 Participants Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 Participants Patients will not receive intraoperative TXA during the HoLEP procedure.
Adverse Events Related to TXA	0 Participants	0 Participants

Adverse Events

TXA Intraoperatively

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

No TXA Intraoperatively

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	TXA Intraoperatively n=55 participants at risk Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 participants at risk Patients will not receive intraoperative TXA during the HoLEP procedure.
Renal and urinary disorders CD IIIb	1.8% 1/55 • Number of events 1 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications	0.00% 0/55 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications

Other adverse events

Measure	TXA Intraoperatively n=55 participants at risk Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.	No TXA Intraoperatively n=55 participants at risk Patients will not receive intraoperative TXA during the HoLEP procedure.
Renal and urinary disorders CD I	12.7% 7/55 • Number of events 55 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications	27.3% 15/55 • Number of events 55 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications
Renal and urinary disorders CD II	3.6% 2/55 • Number of events 2 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications	5.5% 3/55 • Number of events 3 • 90-day complications post-operatively Clavien Dindo classification was used to categorize complications

Additional Information

Nicholas Dean (current fellow)

Northwestern University

Phone: 7806906285

Email: nicholas.dean@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place