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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sangvia® System | Device | Sangvia® Intra- and Post-op System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Need for Bank Blood Transfusion | 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) | At discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf Poolman, Dr. | Onze Lieve Vrouwe Gasthuis (OLVG) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, Department of Orthopaedic Surgery | Vienna | 1090 | Austria | |||
| Onze Lieve Vrouwe Gasthuis (OLVG) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23028549 | Derived | Thomassen BJ, Pilot P, Scholtes VA, Grohs JG, Holen K, Bisbe E, Poolman RW. Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery. PLoS One. 2012;7(9):e44503. doi: 10.1371/journal.pone.0044503. Epub 2012 Sep 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sangvia | Autologous blood transfusion with Sangvia device (routinely) |
| FG001 | No Sangvia | No autologous blood transfusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Amsterdam |
| 1091 HA |
| Netherlands |
| Reinier de Graaf Gasthuis (RdGG), afd. Orthopedie | Delft | 2600 GA | Netherlands |
| MC Haaglanden, Orthopedic Dept. | The Hague | 2501 CK | Netherlands |
| St. Olavs Hospital, Ortopedisk avdelning | Trondheim | 7006 | Norway |
| Hospital Universitario Mar- Esperança (IMAS), Servicio de Anestesiología | Barcelona | 08003 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sangvia | Autologous blood transfusion with Sangvia device (routinely) |
| BG001 | No Sangvia | No autologous blood transfusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Need for Bank Blood Transfusion | 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) | Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled. | Posted | Number | Participants | At discharge |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sangvia | Autologous blood transfusion with Sangvia device (routinely) | 7 | 106 | 12 | 106 | ||
| EG001 | No Sangvia | No autologous blood transfusion. | 7 | 110 | 9 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac insufficiency | Cardiac disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hip dislocation | Injury, poisoning and procedural complications |
| |||
| Infection hip | Infections and infestations |
| |||
| Lung embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Luxation | Injury, poisoning and procedural complications |
| |||
| Paralytic ileus | Gastrointestinal disorders |
| |||
| Periprosthetic fissure (intra-operatively) | Injury, poisoning and procedural complications |
| |||
| Saturation depression | Respiratory, thoracic and mediastinal disorders |
| |||
| Sudden death | General disorders |
| |||
| Suspected infection (positive bacterial culture) | Infections and infestations |
| |||
| Wound infection | Infections and infestations |
| |||
| Wound leakage | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research Area Health Care | Astra Tech AB | +46317763000 |
| >=65 years |
|
| Male |
|
| Austria |
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| Norway |
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| Netherlands |
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