Effect of prophylactic fibrinogen concentrate in surgery of abnormal lateral curvature of the spine: A randomized pilot study (EFISS trial)

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A randomized pilot study (EFISS trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005493-25-CZ

Enrollment

Registered

2022-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis MedDRA version: 20.0 Level: PT Classification code 10039727 Term: Scoliosis surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: HAEMOCOMPLETTAN P 20 MG/ML INJ/INF PLV SOL Product Name: HAEMOCOMPLETTAN P Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Fibrinogenum humanum CAS Num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Diagnosed congenital or acquired coagulopathy 2. Use of anticoagulants with the exception of perioperative prophylactic administration of LMWH to prevent VTE 3. Known hypersensitivity to the active substance or to any of the excipients of IMP 4. History of deep vein thrombosis or pulmonary embolism 5. Pregnancy and lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population.;Secondary Objective: The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.;Primary end point(s): The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population. The following primary endpoint will be monitored to evaluate the primary objective: 1.) Incidence of any adverse events and reactions during participation in the study;Timepoint(s) of evaluation of this end point: will be evaluated at the end of the study	—

Measure

Time frame

Main Objective: The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population.;Secondary Objective: The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.;Primary end point(s): The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population. The following primary endpoint will be monitored to evaluate the primary objective: 1.) Incidence of any adverse events and reactions during participation in the study;Timepoint(s) of evaluation of this end point: will be evaluated at the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery. Secondary endpoints are as follows: 1.) Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) 2.) Additional safety information 3.) Comparison of demographic characteristics between study groups 4.) Comparison of laboratory values of selected haematological parameters between study groups 5.) Comparison of blood loss level and its compensation between study groups 6.) Feasibility assessment ;Timepoint(s) of evaluation of this end point: Day 28	—

Measure

Time frame

Secondary end point(s): The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery. Secondary endpoints are as follows: 1.) Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) 2.) Additional safety information 3.) Comparison of demographic characteristics between study groups 4.) Comparison of laboratory values of selected haematological parameters between study groups 5.) Comparison of blood loss level and its compensation between study groups 6.) Feasibility assessment ;Timepoint(s) of evaluation of this end point: Day 28

—

Countries

Czech Republic

Contacts

Public ContactMichaela Kubelová

Masarykova univerzita

michaela.kubelova@med.muni.cz00420549493842

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026