Trial Outcomes & Findings for A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty (NCT NCT01285024)

NCT ID: NCT01285024

Last Updated: 2017-04-11

Results Overview

Measure Title: Units of transfusion required

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 109 participants
• Primary outcome timeframe: intraoperative - 1 week postoperative
• Results posted on: 2017-04-11

Participant Flow

Participant milestones

Measure	Control No Vitagel used during total hip arthroplasty	Vitagel Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Overall Study STARTED	49	60
Overall Study COMPLETED	49	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

Baseline characteristics by cohort

Measure	Control n=49 Participants No Vitagel used during total hip arthroplasty	Vitagel n=60 Participants Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.	Total n=109 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 9.4 • n=5 Participants	58.2 years STANDARD_DEVIATION 11.8 • n=7 Participants	58.0 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
BMI	30.1 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants	32.6 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	31.5 kg/m^2 STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: intraoperative - 1 week postoperative

Measure Title: Units of transfusion required

Outcome measures

Measure	Control n=49 Participants No Vitagel used during total hip arthroplasty	Vitagel n=60 Participants Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Transfusion Requirement	1.6 units Standard Deviation 0.5	2.2 units Standard Deviation 1.3

SECONDARY outcome

Timeframe: day of surgery - 1 week postoperative

Total hemoglobin level change from preop to postoperative discharge.

Outcome measures

Measure	Control n=49 Participants No Vitagel used during total hip arthroplasty	Vitagel n=60 Participants Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Total Hemoglobin Level Change	4.8 g/dL Standard Deviation 1.1	4.6 g/dL Standard Deviation 1.2

Adverse Events

Control

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Vitagel

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=49 participants at risk No Vitagel used during total hip arthroplasty	Vitagel n=60 participants at risk Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Vascular disorders PE/DVT	2.0% 1/49 • Number of events 1	1.7% 1/60 • Number of events 1
Surgical and medical procedures Wound drainiage	0.00% 0/49	1.7% 1/60 • Number of events 1

Other adverse events

Measure	Control n=49 participants at risk No Vitagel used during total hip arthroplasty	Vitagel n=60 participants at risk Vitagel applied just prior to closure during total hip arthroplasty Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
Infections and infestations Cellulitis	4.1% 2/49 • Number of events 2	3.3% 2/60 • Number of events 2
Gastrointestinal disorders Urinary Retention/Constipation	2.0% 1/49 • Number of events 1	0.00% 0/60
Surgical and medical procedures Edema with pain	0.00% 0/49	1.7% 1/60 • Number of events 1
General disorders Dizziness	4.1% 2/49 • Number of events 2	0.00% 0/60
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/49	1.7% 1/60 • Number of events 1

Additional Information

President and CEO Cleveland Clinic Florida

Cleveland Clinic

Phone: 216-444-7515

Email: barsouw@ccf.org

Results disclosure agreements

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