Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (NCT05391412) | Clinical Trial Compass
UnknownPhase 4
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery
Czechia32 participantsStarted 2022-06-06
Plain-language summary
EFISS is a prospective, randomized, placebo-controlled trial testing the feasibility, safety and efficacy of prophylactic administration of fibrinogen in paediatric spinal surgery. The study is monocentric and will be conducted in University Hospital Brno, Czech Republic. This is a pilot study in which the primary objective will be to evaluate the feasibility of a clinical trial in 32 selected patients undergoing scoliosis surgery. Participants will be randomized into study groups in a 1:1 allocation ratio and followed up for 28 days after surgery. The expected duration of this clinical trial is 8 months.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age \< 18 years of age at the time of enrolment
ā. Elective scoliosis surgery
ā. Signed the relevant informed consent form (more in Chapter 10.1)
ā. Sexually active participants (ā„ 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:
ā. Women - proper use of a highly reliable method of contraception, i.e. combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable form) or sexual abstinence.
ā. Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.
Exclusion criteria
ā. Diagnosed congenital or acquired coagulopathy
ā. Use of anticoagulants with the exception of perioperative prophylactic administration of Low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE)
What they're measuring
1
Adverse event
Timeframe: through study completion, an average of 6 months
2
Adverse drug reaction
Timeframe: through study completion, an average of 6 months
3
Serious adverse event and reaction
Timeframe: through study completion, an average of 6 months
4
Unexpected adverse reaction
Timeframe: through study completion, an average of 6 months
5
Suspected unexpected serious adverse reaction
Timeframe: through study completion, an average of 6 months