Trial Outcomes & Findings for Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty (NCT NCT01636414)

NCT ID: NCT01636414

Last Updated: 2016-08-22

Results Overview

Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 204 participants
• Primary outcome timeframe: Inpatient Postoperative, on average 3 days after surgery
• Results posted on: 2016-08-22

Participant Flow

Participant milestones

Measure	Hemovac Drain Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Overall Study STARTED	64	66	74
Overall Study COMPLETED	61	60	65
Overall Study NOT COMPLETED	3	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty

Baseline characteristics by cohort

Measure	Hemovac Drain n=61 Participants Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain n=60 Participants Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain n=65 Participants Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.	Total n=186 Participants Total of all reporting groups
Age, Continuous	63.03 years STANDARD_DEVIATION 8.21 • n=93 Participants	63.77 years STANDARD_DEVIATION 7.87 • n=4 Participants	61.07 years STANDARD_DEVIATION 14.31 • n=27 Participants	62.68 years STANDARD_DEVIATION 10.41 • n=483 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	43 Participants n=4 Participants	38 Participants n=27 Participants	106 Participants n=483 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	17 Participants n=4 Participants	27 Participants n=27 Participants	80 Participants n=483 Participants

PRIMARY outcome

Timeframe: Inpatient Postoperative, on average 3 days after surgery

Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups

Outcome measures

Measure	Hemovac Drain n=61 Participants Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain n=60 Participants Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain n=65 Participants Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Blood Transfusion	5 participants	8 participants	1 participants

PRIMARY outcome

Timeframe: Post-operative on day 2 (first day after surgery)

Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.

Outcome measures

Measure	Hemovac Drain n=61 Participants Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain n=60 Participants Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain n=65 Participants Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Change in Hemoglobin Level	-3.95 g/dl Interval -5.0 to -3.1	-3.80 g/dl Interval -4.7 to -3.1	-2.90 g/dl Interval -3.8 to -2.0

Adverse Events

Hemovac Drain

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Re-infusion Drain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tranexamic Drain

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hemovac Drain n=61 participants at risk Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain n=60 participants at risk Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain n=65 participants at risk Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Blood and lymphatic system disorders Occluded superficial femoral artery	0.00% 0/61	0.00% 0/60	1.5% 1/65 • Number of events 1
Surgical and medical procedures Reoperation	1.6% 1/61 • Number of events 1	0.00% 0/60	0.00% 0/65

Other adverse events

Measure	Hemovac Drain n=61 participants at risk Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.	Re-infusion Drain n=60 participants at risk Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.	Tranexamic Drain n=65 participants at risk Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
Surgical and medical procedures Extended hospitalization	3.3% 2/61 • Number of events 2	0.00% 0/60	1.5% 1/65 • Number of events 1

Additional Information

Senior Research Scientist

OrthoCarolina Research Institute

Phone: 704-323-2265

Email: susan.odum@orthocarolina.com

Results disclosure agreements

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