Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256796
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-22
Brief Title:
Fresh Frozen Plasma Transfusion in Acute Organophosphate Poisoning
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mild0-3 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 waterif necessary
Antidotal therapy Atropineeach 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 Germanywill 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 20mlkg given as follows
4 units first day
3 units on second day 2 units on third day
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 mild0-3 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 waterif necessary
Antidotal therapy Atropineeach 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 Germanywill 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 20mlkg given as follows
4 units first day
3 units on second day 2 units on third day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None