Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia.
A comparison in need for bank blood will be made between patients that either receive their own blood back or not.
| Condition | Intervention |
|---|---|
|
Arthroplasty, Replacement, Hip Blood Transfusion Blood Transfusion, Autologous |
Device: Sangvia® System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery |
- Number of Participants in Need for Bank Blood Transfusion [ Time Frame: At discharge ] [ Designated as safety issue: No ]
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)
| Enrollment: | 227 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: Sangvia® System
Sangvia® Intra- and Post-op System
|
| No Intervention: 2 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of informed consent
- Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.
Exclusion Criteria:
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrollment or randomisation of treatment in the present study
- Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
- Suspected severe non-compliance to protocol as judged by the investigator
- Current symptoms of haemophilia
- Current symptoms of hyperkalaemia
- Current symptoms of systemic infection or local infection in the operation field
- Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
- History of or presence of malignant disease with propensity for systemic spread during the last 5 years
- Current or expected use of cytotoxic drugs
- Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration < 11 g/dl (7 mmol/l)
- Use of recombinant erythopoetin
- Use of aprotinin and/or fibrin sealant
- Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
- Women of childbearing age
- Fractures
- Revision/secondary total hip surgery with expected serious bone grafting
Contacts and Locations| Austria | |
| Medical University Vienna, Department of Orthopaedic Surgery | |
| Vienna, Austria, 1090 | |
| Netherlands | |
| Onze Lieve Vrouwe Gasthuis (OLVG) | |
| Amsterdam, Netherlands, 1091 HA | |
| Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie | |
| Delft, Netherlands, 2600 GA | |
| MC Haaglanden, Orthopedic Dept. | |
| The Hague, Netherlands, 2501 CK | |
| Norway | |
| St. Olavs Hospital, Ortopedisk avdelning | |
| Trondheim, Norway, 7006 | |
| Spain | |
| Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología | |
| Barcelona, Spain, 08003 | |
| Study Director: | Rudolf Poolman, Dr. | Onze Lieve Vrouwe Gasthuis (OLVG) |
More Information
No publications provided by Wellspect HealthCare
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wellspect HealthCare |
| ClinicalTrials.gov Identifier: | NCT00822588 History of Changes |
| Other Study ID Numbers: | YA-DRA-0001 |
| Study First Received: | January 13, 2009 |
| Results First Received: | February 18, 2011 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Austria: Ethikkommission Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway:National Committee for Medical and Health Research Ethics Spain: Comité Ético de Investigación Clínica |
ClinicalTrials.gov processed this record on June 18, 2013