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Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06256796
Enrollment
92
Registered
2024-02-13
Start date
2024-08-31
Completion date
2025-05-31
Last updated
2024-02-13

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

Conditions

Organophosphorus Poisoning

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 (

Interventions

OTHERfresh frozen plasma

repeated doses of fresh plasma over 3 days in organophosphate poisoned patients

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mortality rate3 monthesfresh frozen plasma decrease the mortality rate among organophosphate poisoned patients

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026