Here is the design of a clinical trial:

Official Title: Prospective, Multi-center, Randomized, Parallel-control, Superiority Study Comparing Administration of Clotting Factor Concentrates With a Standard Massive Hemorrhage Protocol in Severely Bleeding Trauma Patients.

Included conditions:
- Traumatic Hemorrhage
- Coagulopathy
- Massive Hemorrhage

Study Armgroups:
- {'label': 'Intervention Group- Clotting Factor Concentrates', 'type': 'EXPERIMENTAL', 'description': 'Fibryga + Octaplex (Fibrinogen + PCC)\n\nFibrinogen Concentrate 4g (Fibryga) + Prothrombin Complex Concentrate 2000 IU (Octaplex) in the first and second massive hemorrhage protocol (MHP) packs.', 'interventionNames': ['Biological: Fibrinogen + PCC']}
- {'label': 'Control Group: Standard FP transfusion', 'type': 'ACTIVE_COMPARATOR', 'description': 'Frozen Plasma (FP)', 'interventionNames': ['Biological: Frozen Plasma']}

Interventions:
- {'type': 'BIOLOGICAL', 'name': 'Fibrinogen + PCC', 'description': 'Patients randomized to the intervention group will receive 4g of Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs, if requested.\n\nIf a third MHP pack is required, and thereafter, FC will be administered if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods.\n\nPatients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \\[RBC\\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).', 'armGroupLabels': ['Intervention Group- Clotting Factor Concentrates'], 'otherNames': ['Fibryga + Octaplex']}
- {'type': 'BIOLOGICAL', 'name': 'Frozen Plasma', 'description': '4U FP will be released as part of the first and second MHP packs.\n\nPatients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \\[RBC\\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).\n\nPatients randomized to the control group may receive FC if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods. FC dosing in MHP packs 3 and above will be site-specific and at the discretion of the treating clinician.', 'armGroupLabels': ['Control Group: Standard FP transfusion']}

Primary Outcomes:
- {'measure': 'Composite of total number of Allogeneic Blood Products (ABPs)', 'description': 'The primary endpoint is to demonstrate superiority with respect to the composite number of all ABP units (RBCs, FP and platelets) transfused', 'timeFrame': 'within 24 hours'}

Please estimate the sample size based on the assumption: 
A type I error probability of α=0.025 will be used, with inferences based on the one-sided 97.5% CI from a negative binomial regression model. The power is set at 80%, and a 15% dropout rate is assumed.
Sample size
        The sample size calculation was based on demonstrating superiority in efficacy of the intervention (FC+PCC) compared with the active control (FP), with respect to the primary outcome. To demonstrate that the early administration of FCâPCC is clinically superior to the usual component therapy, with respect to the primary outcome (mean number of ABP units within 24 hours post admission), a type I error probability of Î±=0.025âwill be used. Inferences will be based on the one-sided 97.5% CI derived from the estimated least square means of a negative binomial regression model. Superiority will be concluded if the upper limit of this CI is less than 1.0 (ie, the mean number of ABPs is larger in the control group).
        The superiority design of the FiiRST 2 trial was chosen due to the impact on clinical practice and logistical benefits that FCâPCC may offer. Empirical estimates of the mean number of ABP units within the first 24 hours and its dispersion were based on results of the FIIRST 1 Study.11 In FiiRST 1, the mean (Â±SD) composite number of ABPs was 1.50 (Â±2.51) in the intervention group and 3.06 (Â±5.06) in the control group. A mean difference in 5 units of the composite outcome (eg, mean 15 units in the control group and mean 10 units in the intervention group) is considered as a clinically meaningful difference that should be detected with at least 80% power. This approach was used for power determination, which was calculated as 80% with a sample size of 297, which would suffice to demonstrate the superiority of the investigational treatment under the stated assumptions. The FIIRST 1 study had a 10% patient drop off (exclusions post randomisation for subjects where informed consent could not be obtained and for patients randomised and not treated with any coagulation products in pack 1). In addition, FiiRST 1 had 10% death rate. Hence, we inflated the sample size to account for a drop-out percentage by 15% for a final sample estimate of 350 patients.