Methods
PPH, thromboembolic, bleeding, blood loss
BLEEDING, CLOT, BLOOD LOSS, LYSIS, MAY, SECONDARY, POSTPARTUM HAEMORRHAGE, COMPLICATIONS, TRANSFUSION REACTIONS
This was a single-centre, single-blinded, randomised controlled trial. The protocol was approved by the ethics committee of Pirkanmaa Hospital District (PSHP) and conducted in its tertiary referral centre, Tampere University Hospital (Tampere, Finland; ethics committee reference number R15054). Registration of the protocol was made in May 2015 at From January of 2016, women over age 18 yr with severe PPH (active bleeding of >1000 ml despite use of initial measures such as uterotonic agents and uterine massage after vaginal delivery thus requiring an intervention in the operating theatre or during/after Caesarean delivery) were included in the study.The Consolidated Standards of Reporting Trials (CONSORT) diagram is presented in CONSORT diagram. CONSORT, Consolidated Standards of Reporting Trials; PPH, postpartum haemorrhage; ROTEM, rotational thromboelastometry.After randomisation, initial blood samples were collected mainly through an arterial line including ROTEM Extem and Fibtem, blood count, aPTT, thromboplastin time as international normalised ratio (TT-INR), Clauss fibrinogen, and blood gas analysis with lactate measurement. During bleeding and postoperative surveillance, this testing was repeated if considered necessary by the anaesthesiologist, and 12–24 h after bleeding without arterial blood gas and lactate measurements. ROTEM measurements were also made in the control group but were not followed by the caregivers. The amount of blood loss was visually estimated before entering the operating theatre and after that, swabs and towels were weighed and the weight of dry items subtracted from the total to get blood weight; blood volume in suction canisters was directly measured and in Caesarean delivery, the estimated amount of amniotic fluid was subtracted from this figure.The protocols for both groups are shown in Intervention (ROTEM) group protocol. A5, clot amplitude at 5 min in ROTEM; aPTT, activated partial thromboplastin time; CT, clotting time; INR, international normalised ratio; IU, international unit; LMWH, low-molecular-weight heparin; MCF, maximal clot firmness; ML, maximal lysis percentage; ROTEM, rotational thromboelastometry; TXA, tranexamic acid. ∗For example, if systemic systolic arterial pressure under <90 mm Hg and pressured infusion of crystalloid fluids or blood products is needed to maintain arterial pressure.Control group protocol. aPTT, activated partial thrombin time; INR, international normalised ratio; IU, international unit; LMWH, low-molecular-weight heparin; SAP, systolic arterial pressure; TXA, tranexamic acid. ∗For example, if systemic systolic arterial pressure <90 mm Hg and pressured infusion of crystalloid fluids or blood products is needed to maintain arterial pressure.The anaesthesiologist was allowed to administer Ringer's acetate or albumin (Albuman®; Sanquin Plasma Products B.V.) to correct blood volume. Transfusion of blood products was not limited only according to haemoglobin or haemostatic measurements according to the protocols but also based on clinical judgement. The MTP (Participants were blinded. The attending anaesthesiologist and the anaesthetic nurse knew the assigned protocol, but the obstetric team assessing the amount of total blood loss was not informed. As for other outcome measurements, the assessor and the statistical analyst were blinded until the first draft of the manuscript. Data were collected with a case report form during and immediately after the bleeding but also afterwards through electronic patient records. Some information was tracked from manual patient files such as anaesthesia records. The number of transfused blood product units during the hospital stay was the primary endpoint; secondary endpoints were the number of transfusion reactions and thromboembolic complications within a 30-day period postpartum.