Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning

Organophosphorus Poisoning Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256796
• Other study ID #: plasma in OP poisoning
• Status: Recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 (

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Organophosphate Poisoning
• Organophosphorus Poisoning
• Poisoning

Intervention

Other:
• fresh frozen plasma
repeated doses of fresh plasma over 3 days in organophosphate poisoned patients

Locations

Country	Name	City	State
Egypt	faculty of medicine Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients	3 monthes