A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial

Abstract

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Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial

“…At present, some medical institutions around the world have carried out autologous blood recovery from amniotic fluid in the operation field after delivery and placenta separation and filtration of white blood cells without leading to obvious puerperal complications [13]. Although the technique has been confirmed to be safe by multiple studies with large clinical sample sizes [14], its promotion has currently encountered some taboos. For example, pregnant patients with malignant tumours and patients with sickle cell anaemia were excluded.…”

Anästhesiologisches Management der peripartalen Hämorrhagie

“…Die Nutzung maschineller Autotransfusionssysteme (MAT) bei PPH wird von praktisch allen internationalen geburtshilflichen Leitlinien (AAGBI, ASA, CMACE, ESA, NICE) empfohlen. Bei standardmäßiger Nutzung eines MAT bei jeder Sectio ergaben sich in aktuellen Studien retransfundierte Volumina von rund 250 ml [20,21].…”

“…Es empfiehlt sich, initial immer mit "nur Sammeln" zu beginnen (d. h. nur Reservoir aufbauen). Wird erst bei Bedarf zusätzlich mit "Waschen" begonnen (d. h. auch Glocke und Schläuche anschließen), wird das Verfahren auch kosteneffektiv [20]. Einige Autoren empfehlen eine "Strategie der 2 Sauger": Das bedeutet ein regulärer OP-Sauger wird benutzt zur Uterotomie und zum Absaugen des Fruchtwassers, dann erst wird das Saugersystem des MAT angewandt.…”

Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project

“…demographics, primary outcomes, secondary outcomes), our experience of running trials (e.g. data required to identify participants or link data) and our experience of initial attempts to apply the list to trial data collection forms (case report forms [CRFs] and participant questionnaires) from three trials (AMBER [13], KAT [14] and SALVO [15]). We identified these trials primarily from personal involvement with the trial; none was a Clinical Trial of an Investigational Medicinal Product (CTIMP).…”

“…Some data items were hard to categorise, and discrepancies often involved one of the two reviewers using 'Miscellaneous' where the other did not. For example, in SALVO [15] 'Mother ABO blood group' was initially categorised as 'Miscellaneous' by one person and 'Medical history' by the other. After discussion the two team members agreed that in this case this data item was best described as 'Miscellaneous'.…”