Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning

February 11, 2024 updated by: Ain Shams University

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.

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Medicine Ain Shams University
        • Contact:
        • Contact:
          • Soha Ashry, professor
          • Phone Number: 01114041404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: moderate group controlled patients
Experimental: moderate group study patients
Other: fresh frozen plasma
repeated doses of fresh plasma over 3 days in organophosphate poisoned patients
No Intervention: sever controlled group
Experimental: sever study group
Other: fresh frozen plasma
repeated doses of fresh plasma over 3 days in organophosphate poisoned patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: 3 monthes
fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients
3 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • plasma in OP poisoning

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Organophosphorus Poisoning

Clinical Trials on fresh frozen plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe