FORMA 10 Trial

FORMA-10 was a retrospective, observational, noninterventional study in patients with fibrinogen deficiency receiving fibrinogen concentrate from December 2017 to February 2020. A hundred and fifty adult and 50 paediatric patients with acquired fibrinogen deficiency were included in the analysis.

Primary objective

To describe the cause of bleeding for the administration of fibrinogen concentrate for an ongoing bleeding event.

Secondary objective

To describe the proportion of treatment successes for on-demand treatment of nonsurgical surgical bleeding events and perioperative prophylaxis

Outcomes

Bleeding characteristics:

• Fibrinogen concentrate was administered to adult patients for nonsurgical bleeding 71(47.3%), surgical bleeding 34 (22.7%), and perioperative prophylaxis 45 (30.0%).

• The most common indication for fibrinogen concentrate in paediatric population was perioperative prophylaxis (48/50) patients, 96.0%.

Treatment success:

• Treatment success for fibrinogen concentrate, defined as bleeding control for on-demand treatment of nonsurgical and surgical bleeding events and the absence of major perioperative bleeding for perioperative prophylaxis, was >84.0% in all treatment categories for adult patients.

• Fibrinogen concentrate treatment success for paediatric perioperative prophylaxis was 87.5%

Safety:

No ADRs were documented for either age group.