Trial Outcomes & Findings for Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not (NCT NCT00822588)

Last Updated: 2012-10-04

Results Overview

Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared. The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)

Recruitment status

COMPLETED

Study phase

Target enrollment

227 participants

Primary outcome timeframe

At discharge

Results posted on

2012-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sangvia Autologous blood transfusion with Sangvia device (routinely)	No Sangvia No autologous blood transfusion.
Overall Study STARTED	113	114
Overall Study COMPLETED	106	110
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sangvia n=106 Participants Autologous blood transfusion with Sangvia device (routinely)	No Sangvia n=110 Participants No autologous blood transfusion.	Total n=216 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=93 Participants	49 Participants n=4 Participants	93 Participants n=27 Participants
Age, Categorical >=65 years	62 Participants n=93 Participants	61 Participants n=4 Participants	123 Participants n=27 Participants
Age Continuous	67 years STANDARD_DEVIATION 11 • n=93 Participants	65 years STANDARD_DEVIATION 12 • n=4 Participants	66 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	76 Participants n=93 Participants	70 Participants n=4 Participants	146 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	40 Participants n=4 Participants	70 Participants n=27 Participants
Region of Enrollment Spain	5 participants n=93 Participants	5 participants n=4 Participants	10 participants n=27 Participants
Region of Enrollment Austria	12 participants n=93 Participants	13 participants n=4 Participants	25 participants n=27 Participants
Region of Enrollment Norway	7 participants n=93 Participants	6 participants n=4 Participants	13 participants n=27 Participants
Region of Enrollment Netherlands	82 participants n=93 Participants	86 participants n=4 Participants	168 participants n=27 Participants

PRIMARY outcome

Timeframe: At discharge

Population: Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.

Outcome measures

Outcome measures
Measure	Sangvia n=96 Participants Autologous blood transfusion with Sangvia device (routinely)	No Sangvia n=101 Participants No autologous blood transfusion.
Number of Participants in Need for Bank Blood Transfusion	9 Participants	13 Participants

Adverse Events

Sangvia

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

No Sangvia

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sangvia n=106 participants at risk Autologous blood transfusion with Sangvia device (routinely)	No Sangvia n=110 participants at risk No autologous blood transfusion.
Cardiac disorders Cardiac insufficiency	0.94% 1/106 • Number of events 1	0.00% 0/110
Metabolism and nutrition disorders Dehydration	0.94% 1/106 • Number of events 1	0.00% 0/110
Injury, poisoning and procedural complications Hip dislocation	0.94% 1/106 • Number of events 1	0.00% 0/110
Infections and infestations Infection hip	0.00% 0/106	0.91% 1/110 • Number of events 1
Respiratory, thoracic and mediastinal disorders Lung embolism	0.00% 0/106	0.91% 1/110 • Number of events 1
Injury, poisoning and procedural complications Luxation	0.00% 0/106	0.91% 1/110 • Number of events 1
Gastrointestinal disorders Paralytic ileus	0.94% 1/106 • Number of events 1	0.00% 0/110
Injury, poisoning and procedural complications Periprosthetic fissure (intra-operatively)	0.00% 0/106	0.91% 1/110 • Number of events 1
Respiratory, thoracic and mediastinal disorders Saturation depression	0.94% 1/106 • Number of events 1	0.00% 0/110
General disorders Sudden death	0.00% 0/106	0.91% 1/110 • Number of events 1
Infections and infestations Suspected infection (positive bacterial culture)	0.94% 1/106 • Number of events 1	0.00% 0/110
Infections and infestations Wound infection	0.00% 0/106	0.91% 1/110 • Number of events 1
Injury, poisoning and procedural complications Wound leakage	0.94% 1/106 • Number of events 1	0.91% 1/110 • Number of events 1

Other adverse events

Other adverse events
Measure	Sangvia n=106 participants at risk Autologous blood transfusion with Sangvia device (routinely)	No Sangvia n=110 participants at risk No autologous blood transfusion.
Gastrointestinal disorders Nausea	11.3% 12/106	8.2% 9/110

Additional Information

Head of Clinical Research Area Health Care

Astra Tech AB

Phone: +46317763000

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60