Leukocyte Depletion of Autologous Whole Blood (LDAWB-2001)
Tracking Information | |||||
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First Received Date ICMJE | September 11, 2005 | ||||
Last Updated Date | June 9, 2008 | ||||
Start Date ICMJE | April 2001 | ||||
Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay | ||||
Change History | Complete list of historical versions of study NCT00176124 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Blood loss and transfusion rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Blood loss and transfusion rate | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Leukocyte Depletion of Autologous Whole Blood | ||||
Official Title ICMJE | Leukocyte Depletion of Autologous Whole Blood: Impact on Perioperative Infection Rate and Length of Hospital Stay for Hip Arthroplasty Patients | ||||
Brief Summary | Leukocyte depletion of autologous whole blood prior to storage does not reduce infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion rate |
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Detailed Description | Informed Consent Form: Prior to the first blood donation, in- and exclusion criteria should be tested. Then the patient is to inform by the investigator about the studies aim and participation conditions such as methods, risks, assurance, data security, etc. The patient and the investigator should sign the informed consent form. Randomization: If all inclusion criteria are well given and exclusion criteria are absent, the patient could be enrolled and randomized, prior to the first PAD. Enrollment is parallel in all centers until the final number of 1088 is reached. Breaking the seal of the provided randomization envelope with computerized randomization codes completes randomization. Time and date should be noted. Blinding: Randomization is done by the investigator, which should manage the blood donation. The blood bags after inline leukocyte depletion prior to storage do not look different from not depleted bags and are labeled only with the patient's identity and the subjects ID. The allocation to the group is to keep secret from patient, surgeon and anesthesiologist. Treatment: A PAD: Group 1 Preoperative Donation of multiple units ( more than 2) 450 mL autologous whole blood and storage without leukocyte depletion Usual criteria and methods of PAD are used according to regional guidelines of blood donations in the respective center. Group 2 Preoperative Donation of multiple units (more than 2) 450 mL autologous whole blood and storage following leukocyte depletion 2 to 4 hours after whole blood donations, the whole blood bags should be in-line filtered by the use of leukocyte filtration sets (provided by Pall Medical Company). Storage as in group 1 at 4 degree C in a blood fridge. A as proposal, the Mannheim concept reveals a 95 percent security in avoidance of allogenic transfusions for a blood loss of 20-25 ml per kg body weight: Intended are 3 donations in weekly intervals. If Hb plasma con-tent decreases below 11 g/dL, the donation will be postponed to the fol-lowing week. Surgery is at the fifth week after the first donation. B Anesthesia and Surgery: As usual in the center, and without a difference between the two groups anesthesia and surgery should be performed under following aspects:
Further documentation of
Parameter: • Skin inspection Criteria of wound infection:
Woundhealing and the occurrence of infections were classified with the ASEPSIS score: Of influence is the duration of antibiotic treatment, drainage of pus, wound de-bridements, erythema, involvement of deeper tissue layers, identification of bacteria, LOS above 14 days 17. Infection Definition Occurrence of any infection is defined as
Wound infection is assessed by the ASEPSIS score Urinary tract infection is defined as
Respiratory airway infection is defined as
Septicemia is defined as • clinical symptoms and positive blood culture |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 1089 | ||||
Completion Date | September 2005 | ||||
Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Germany | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00176124 | ||||
Other Study ID Numbers ICMJE | UniKlinMa-TF-2001-1, ISRCTN 99578441 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Thomas Frietsch, MD PhD, University of Heidelberg | ||||
Study Sponsor ICMJE | University of Heidelberg | ||||
Collaborators ICMJE | Philipps University Marburg Medical Center | ||||
Investigators ICMJE |
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Information Provided By | University of Heidelberg | ||||
Verification Date | June 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |