Restrictive versus liberal fluid administration strategy (REFILL study) in postpartum hemorrhage and its effects on thromboelastometry (ROTEM®) values: a randomized, controlled trial.

OBJECTIVE: Current obstetric guidelines for postpartum hemorrhage (PPH) vary in fluid resuscitation management. This study aimed to evaluate the effect of fluid management on coagulation parameters in early PPH. METHODS: We performed a multicenter, randomized trial. Women who had 500 mL of blood loss in the third stage of labor were randomized to receive a restrictive fluid administration strategy or a liberal fluid administration strategy. A rotational thromboelastometry panel was performed in 72 patients. We evaluated within-group and between-group differences in the EXTEM clotting time (CT), EXTEM amplitude at 10 minutes (A10), INTEM CT, and FIBTEM A10. We also evaluated the mean fibrinogen concentration, activated partial thromboplastin time, and partial thromboplastin time in the total study population (n = 249). RESULTS: There were no significant differences in hemostatic parameters between the groups after correction for baseline values. CONCLUSIONS: In women with PPH <1500 mL, there is no clinically relevant effect of a restrictive or liberal fluid administration strategy on thromboelastometric hemostatic and regular coagulation parameters.

Restrictive versus liberal fluid resuscitation strategy, influence on blood loss and hemostatic parameters in mild obstetric hemorrhage: An open-label randomized controlled trial. (REFILL study).

BACKGROUND: Evidence for optimal hemostatic resuscitation in postpartum hemorrhage (PPH) is lacking. Liberal fluid administration may result in acidosis, hypothermia and coagulopathy. OBJECTIVE: We hypothesize that in early PPH a restrictive fluid administration results in less progression to moderate PPH. STUDY DESIGN: In four Dutch hospitals we recruited women of 18 years and over, and more than 24 weeks pregnant. Exclusion criteria were: anticoagulant therapy, known coagulation disorders, pre-eclampsia, antenatal diagnosis of abnormally adhesive placenta, and a contraindication for liberal fluid therapy. We blindly randomized participants at 500 mL and ongoing blood loss in the third stage of labor between restrictive fluid administration (clear fluids 0.75-1.0 times the volume of blood lost) and liberal fluid administration (clear fluids 1.5-2.0 times the volume of blood lost). The primary outcome was progression to more than 1000 mL blood loss. Analyses were according to the intention-to-treat principle. RESULTS: From August 2014 till September 2019, 5190 women were informed of whom 1622 agreed to participate. A total of 252 women were randomized of which 130 were assigned to the restrictive group and 122 to the liberal group. In the restrictive management group 51 of the 130 patients (39.2%) progressed to more than 1000 mL blood loss versus 61 of the 119 patients (51.3%) in the liberal management group (difference, -12.0% [95%-CI -24.3% to 0.3%], p = 0.057). There was no difference in the need for blood transfusion, coagulation parameters, or in adverse events between the groups. CONCLUSIONS: Although a restrictive fluid resuscitation in women with mild PPH could not been proven to be superior, it does not increase the need for blood transfusion, alter coagulation parameters, or cause a rise in adverse events. It can be considered as an alternative treatment option to liberal fluid resuscitation. TRIAL REGISTRATION: NTR3789.

Liberal or restrictive fluid management during elective surgery: a systematic review and meta-analysis.

This article reviews if a restrictive fluid management policy reduces the complication rate if compared to liberal fluid management policy during elective surgery. The PubMed database was explored by 2 independent researchers. We used the following search terms: "Blood transfusion (MESH); transfusion need; fluid therapy (MESH); permissive hypotension; fluid management; resuscitation; restrictive fluid management; liberal fluid management; elective surgery; damage control resuscitation; surgical procedures, operative (MESH); wounds (MESH); injuries (MESH); surgery; trauma patients." A secondary search in the Medline, EMBASE, Web of Science, and Cochrane library revealed no additional results. We selected randomized controlled trials performed during elective surgeries. Patients were randomly assigned to a restrictive fluid management policy or to a liberal fluid management policy during elective surgery. The patient characteristics and the type of surgery varied. All but 3 studies reported American Society of Anaesthesiologists groups 1 to 3 as the inclusion criterion. The primary outcome of interest is total number of patients with a complication and the complication rate. Secondary outcome measures are infection rate, transfusion need, postoperative rebleeding, hospital stay, and renal function. In total, 1397 patients were analyzed (693 restrictive protocol, 704 liberal protocol). Meta-analysis showed that in the restrictive group as compared with the liberal group, fewer patients experienced a complication (relative risk [RR], 0.65; 95% confidence interval [CI], 0.55-0.78). The total complication rate (RR, 0.57; 95% CI, 0.52-0.64), risk of infection (RR, 0.62; 95% CI, 0.48-0.79), and transfusion rate (RR, 0.81; 95% CI, 0.66-0.99) were also lower. The postoperative rebleeding did not differ in both groups: RR, 0.76 (95% CI, 0.28-2.06). We conclude that compared with a liberal fluid policy, a restrictive fluid policy in elective surgery results in a 35% reduction in patients with a complication and should be advised as the preferred fluid management policy.