IHT carries significant SIs and AEs in severe TBI patients. To improve a risk/benefit ratio favorable for patients, a program focusing on IHT complications regarding therapeutic impact of control CT scan is needed.
Objective
To assess the benefits and safety of early human fibrinogen concentrate in postpartum haemorrhage (PPH) management.
Design
Multicentre, double‐blind, randomised placebo‐controlled trial. Setting: 30 French hospitals.
Population
Patients with persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins.
Methods
Within 30 minutes after introduction of prostaglandins, patients received either 3 g fibrinogen concentrate or placebo.
Main outcome measures
Failure as composite primary efficacy endpoint: at least 4 g/dl of haemoglobin decrease and/or transfusion of at least two units of packed red blood cells within 48 hours following investigational medicinal product administration. Secondary endpoints: PPH evolution, need for haemostatic procedures and maternal morbidity–mortality within 6 ± 2 weeks after delivery.
Results
437 patients were included: 224 received FC and 213 placebo. At inclusion, blood loss (877 ± 346 ml) and plasma fibrinogen (4.1 ± 0.9 g/l) were similar in both groups (mean ± SD). Failure rates were 40.0% and 42.4% in the fibrinogen and placebo groups, respectively (odds ratio [OR] = 0.99) after adjustment for centre and baseline plasma fibrinogen; (95% CI 0.66–1.47; P = 0.96). No significant differences in secondary efficacy outcomes were observed. The mean plasma FG was unchanged in the Fibrinogen group and decreased by 0.56 g/l in the placebo group. No thromboembolic or other relevant adverse effects were reported in the Fibrinogen group versus two in the placebo group.
Conclusions
As previous placebo‐controlled studies findings, early and systematic administration of 3 g fibrinogen concentrate did not reduce blood loss, transfusion needs or postpartum anaemia, but did prevent plasma fibrinogen decrease without any subsequent thromboembolic events.
Tweetable abstract
Early systematic blind 3 g fibrinogen infusion in PPH did not reduce anaemia or transfusion rate, reduced hypofibrinogenaemia and was safe.
y Authors' affiliations 1 and 2 are current affiliations, affiliation 5 is where the work was carried out. z The members of the CAESAR working group are listed in acknowledgement section.
Use of both patent blue and a radioisotope to locate, and reduce the risk of sentinel lymph node (SLN) detection failure in breast cancer is recommended, but drawbacks commonly lead to using only a radioisotope. An alternative method would therefore be valuable. This randomized, controlled study in 99 patients compared SLN detection using
99m
technetium (Tc) alone versus Tc combined with indocyanine green (ICG). The primary endpoint was the SLN identification rate. The primary outcome measure was the number of patients with <2 SLN detected. One SLN was detected in 44.0% of patients in the dual detection group and 40.8% in the
99m
Tc alone group (RR = 1.08 (95% CI 0.68; 1.72), p = 0.84). A mean (±SD) of 2.14 ± 1.23 SLN were identified in the dual detection group
vs
. 1.77 ± 0.85 using Tc alone (
p
= 0.09). Eight-five (78.7%) SLN were both ICG+ and TC+, 15 (13.9%) ICG+ and Tc−, and 7 (6.5%) ICG− and Tc+. SLN detected were ICG-positive in 92.6% of patients and
99m
Tc-positive in 85.2% with. No adverse event related to ICG injection was recorded. Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.
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