Wound Drainage With or Without Blood Salvage? An Open, Prospective, Randomized and Single-Center Comparison of Blood Loss, Postoperative Hemoglobin Levels and Allogeneic Blood Transfusions After Major Hip Surgery

Robert Slappendel, MD, PhD; Wieger Horstmann, MD; Ris Dirksen, MD, PhD; Gijs G. Van Hellemondt, MD

Disclosures

Transfusion Alter Transfusion Med. 2008;10(4):174-181. 

In This Article

Methods

The study was an open, randomized prospective and single-center study with two parallel treatment groups. After approval of the ethics committee, 200 patients scheduled for revision total hip surgery were randomized to either the Bellovac ABT (autologous blood salvage, low vacuum) or to a Medinorm AG (Medinorm AG, Quierschied, Germany) (high vacuum) drainage system, where retransfusion of salvage blood is not possible. Before inclusion, all patients were required to fulfill the inclusion criteria (i.e. provision of written informed consent, age > 45 years and patient subjected to revision total hip surgery) and none of the exclusion criteria (i.e. coagulation disorders, malignancy, ongoing infections, untreated hypertension, unstable angina pectoris, myocardial infarction within the past 12 months, bypass operation within the past 12 months, intake of anticoagulants or participation in other clinical trials dealing with any drugs that influences blood loss). Furthermore, only procedures where the duration of surgery was at least 60 minutes were considered major surgery relevant for revision hip surgery and interesting to study in an efficacy analysis. When it had been verified that the patient fulfilled all eligibility criteria, the patient was scheduled for surgery. Randomization was done at the end of surgery, immediately before the drainage system was connected.

Blood loss and transfusion volumes were registered during surgery, and for 3 day post-surgery. Blood loss was calculated by the amount of intraoperative cell saving volume, weighing the intraoperative gauzes and postoperative draining volumes. Type of transfusion (i.e. postoperative autologous filtered, intraoperative autologous washed or allogeneic) was registered. Also predonated blood volumes returned to the patients were registered. The hemoglobin concentration was measured before surgery, 1 hour after the end of surgery and then once a day on days 1, 2, 3, 4, 5, 6, 7, 10 post-surgery and on the day of discharge. Duration of surgery and length of hospital stay were also registered. To minimize differences between the two groups, all other factors concerning blood loss were kept constant.

The blood management process was according to ISO standard NEN-EN-ISO 9001:2000 certified by TUV (TUV Nederland QA BV, Best, the Netherlands), as follows:

  • Venous thromboembolism prophylaxis was performed using nadroparin 0.3 mL (2850 anti-Xa IU; Sanofi Synthelabo BV, Gouda, the Netherlands) subcutaneously once daily. The first dose was given 4 hours after surgery.

  • The trigger for allogeneic transfusions was a hemoglobin level of 6.4 g/dL in patients below 60 years and 8.0 g/dL in patients 60 years and older.

  • The cox-2-selective non-steroidal anti-inflammatory drug meloxicam 15 mg once daily was used in all patients starting 1 hour preoperatively.

  • Perioperative cell saving and washing was used in all patients (Cell saver Haemonetics 5 plus; Haemonetics BV, Tilburg, the Netherlands).

  • Epoetin alpha 40,000 IU was given three times subcutaneously at a weekly interval in patients with a preoperative hemoglobin level between 10 and 13 g/dL.

Appropriate descriptive statistics (mean, range, frequency tables, etc.) were used to analyze the data. All statistical comparisons between the two treatment groups were tested with either the Wilcoxon rank sum test or the Fisher's exact test, and a P-value of 0.05 or lower was considered statistically significant. Statistical tests where all run on per-protocol patients valid for the efficacy analysis.

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