NCT06256796

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 13, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

January 22, 2024

Last Update Submit

February 11, 2024

Conditions

Organophosphorus Poisoning

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    fresh frozen plasma decrease the mortality rate among organophosphate poisoned patients

    3 monthes

Study Arms (4)

moderate group controlled patients

NO INTERVENTION

moderate group study patients

EXPERIMENTAL
Other: fresh frozen plasma

sever controlled group

NO INTERVENTION

sever study group

EXPERIMENTAL
Other: fresh frozen plasma

Interventions

fresh frozen plasmaOTHER

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

moderate group study patientssever study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Ain Shams University

Cairo, Egypt

RECRUITING

Related 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.

    PMID: 27212759BACKGROUND

MeSH Terms

Conditions

Organophosphate Poisoning

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 13, 2024

Study Start

August 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

February 13, 2024

Record last verified: 2024-01

Locations

EG(1)