“The effect of duration of wound drainage on allogeneic blood transfusions using a postoperative retransfusion system after major orthopaedic surgery.”

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26356

Enrollment

570

Registered

2010-09-09

Start date

2010-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

retransfusion, retransfusie drain joint arthroplasty, gewrichtsvervanging duration, tijd

Interventions

Autologous retransfusion drainage with the Bellovac® ABT retransfusion system. After inclusion, patients are randomised into three groups: 1. Group 1: No drainage

2. Group 2: Drainage for 6 hours after surgery

3. Group 3: Drainage for 24 hours after surgery. Randomisation with sealed envelopes (stratification per clinic) will be done at the end of surgery just before wound closure. Shed blood in group 2 an

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo elective major orthopaedic surgery (hip, knee); 2. Male and non-pregnant female patients between 18-80 years of age; 3. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule; 4. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with a major surgical procedure during the 12 weeks before the study-related operation; 2. No other used alternatives to reduce allogeneic blood transfusions, such as preoperative epoetin alpha (Eprex®) injections or intra-operative cell saving (Sangvia®); 3. Clinical or laboratory evidence of untreated iron, folate or vitamin B12 deficiency; 4. Recent Myocardial Infarction or CVA (<3 months); 5. Dutch language not mastered; 6. The patient is pregnant or planning a pregnancy after surgery (or is using inadequate birth control); 7. Mentally disabled patients; 8. Current malignancy or any active infection.

Design outcomes

Primary

Measure	Time frame
Allogeneic blood transfusion rate.	—

Secondary

Measure	Time frame
1. Haemoglobin level (pre-operative, 24 and 72 hrs after operation); 2. Amount of blood collected with Bellovac ABT at 6 hours and 24 hours; 3. Complications, especially wound problems; 4. Length of hospital stay; 5. Co morbidity.	—

Contacts

Public ContactB.J.W. Thomassen

Haaglanden Medical Center PO Box 432

b.thomassen@mchaaglanden.nl+31 (0)70 3303109

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)