Clinical trial NCT06256796: Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning
Official title: Evaluation of Effectiveness of Fresh Frozen Plasma Transfusion as a Novel Adjuvant Treatment in Acute Organophosphate Poisoned Patients. A Randomized Clinical Trial in Poison Control Center Ain Shams University Hospital.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Organophosphorus Poisoning
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study clinical trial to assess the role of fresh frozen plasma as a novel available and easy to be applied rather than conventional therapy on organophosphate poisoned patients and prediction of it is prognosis on selected patients and it is effect on outcome .

Detailed description: a prospective randomized clinical trail study . this study will be conducted in poison control center Ain shas university hospital -Egypt . all adult patients of both sexes admitted , in Poison Control Center of Ain Shams University Hospitals (PCC-ASUH) with diagnosis of moderate and severe degree of organophosphate poisoning will be included in this study.

The severity of patients under the study will be assessed at the time of presentation using the PeradeniyaOrganophosphorus Poisoning (POP) scale The severity will be graded as mild(0-3), moderate (4-7), and sever (8- 11).

The included patients in this study will be randomly divided into two groups as follow:

Group A: Patients who will be treated according to traditional management protocol of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) as follow:

* Supportive measures and patients resuscitation.
* Decontamination: patients presenting within 4hr of OP ingestion will be subjected to gastric lavage and all patients with oral exposure will be given a single (30 mg) dose of activated charcoal. Any contaminated material will be discarded and dermal contamination will be carried out using soap and water,if necessary.
* Antidotal therapy: Atropine(each ampoule contains 1mg of atropine per ml) will be given as bolus doses of 2-5 mg IV and repeated every10-15 min until dryness of chest secretions, and then atropine injections maintenance doses will be given intermittently to patients as needed .Toxogonin (each ampoule contains 250mg of obidoxime chloride in 1 ml, produced by Merck, Darmstadt, Germany)will be administered as a loading dose of 250 mg, and will be repeated every 8 hrs until at least 12hrs after atropine no longer required.

This group of patients will be divided in to :

GroupA1 will include moderate degree of acute OP poisoned patients (POP scale 4-7) Group A2 will include severe degree of acute OP poisoned patients (POP scale 8-11)

Group B: Patients who will be treated with conventional therapy of OPC toxicity in the form of: supportive measures, decontamination and antidotal therapy (atropine \&Oximes) in addition to fresh frozen plasma (FFP).

FFP will be given after one hour of hospitalization (time needed to prepare FFP to the patients and to finish emergency management) in dose of 20ml\\kg given as follows:

* 4 units first day
* 3 units on second day 2 units on third day (

Eligibility criteria: Inclusion Criteria:

-moderate and severe degree of organophosphate poisoning will be included in this study.

Exclusion Criteria:

* patients below 18 years or above 60 years.
* Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.
* Pregnant female
* Patients suspected of having mixed or unknown exposure
* Patients with coagulation disorders.
* Patients with hyper sensitivity to FFP or plasma derived products, as these cases are contraindicated to take fresh frozen plasma

Primary outcomes:
measure: mortality rate
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Ain Shams University
Study officials:
References:
citation: Dayananda VP, Bhaskara B, Pateel GN. A study of effectiveness of fresh frozen plasma in organophosphorous compound poisoning in reducing length of Intensive Care Unit stay and in reducing need for tracheostomy. Anesth Essays Res. 2016 May-Aug;10(2):268-72. doi: 10.4103/0259-1162.171455.