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Trial record 17 of 826 for:    Recruiting, Not yet recruiting, Available Studies | Bleeding

Platelet Rich Plasma in Bleeding Peptic Ulcer (PRP)

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ClinicalTrials.gov Identifier: NCT03733171
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Shaaban Hanafy, Zagazig University

Brief Summary:

The most common cause of acute upper gastrointestinal bleeding (UGIB) is non-variceal, where peptic ulcer bleeding (PUB) remains the single most common cause, accounting for 25% to 67% of the causes of non-variceal upper gastrointestinal bleeding (NVUGIB).

Despite major advances in diagnostic and therapeutic tools, PUB remains a significant problem and an important cause of morbidity and mortality. Given the imperative therapeutic role of endoscopic management in achieving hemostasis in NVUGIB, new modalities to improve the current treatment strategies continue to be developed.

Platelet-rich plasma (PRP) is a widely used throughout many fields of medicine for improving tissue regeneration. PRP contains a higher concentration of platelets than whole blood, and represents a pool of many growth-factors.


Condition or disease Intervention/treatment Phase
Bleeding Ulcer Drug: PLATELET RICH PLASMA Drug: diluted epinephrine Not Applicable

Detailed Description:

All patients were subjected to full history taking, complete clinical examination, laboratory investigations (complete blood count, liver and kidney function tests, coagulation profile), ECG and Upper GI endoscopy was performed within 24 hours of hospital admission after initial resuscitation of patients including blood transfusion if HB level ≤ 7g ∕ L.

Stigmata of recent hemorrhage was defined according to the Forrest (F) classification (FIa- spurting hemorrhage, FIb- oozing hemorrhage, FIIa- non-bleeding visible vessel, FIIb- adherent clot, FIIc- flat pigmented spot and FIII- clean base ulcer).The size of an ulcer was classified as < 2 cm or ≥ 2cm.

  • PRP or diluted epinephrine were injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle.
  • Group I was subjected to multiple injection of PRP (each 1-2 ml), while group II was subjected to epinephrine injections (each 1-2 ml of a 1:10.000 solution of epinephrine) .
  • Hemostasis was achieved if bleeding stopped for at least 3 min of observation. Immediately after the endoscopic hemostasis, PPIs were infused at a standard regimen (40 mg bolus of PPI once daily for 72 h) or at a high-dose regimen (loading dose of 80 mg on the first day followed by continuous infusion of 8 mg/h for 72 h), after the initial 72 h, patients were switched to oral PPIs (20 mg twice daily) until discharge .

PRP preparation method

Under complete aseptic conditions the blood was drawn with the addition of anticoagulant such as citrate dextrose A to prevent platelet activation prior to its use.

1.30-60 cc of patients' blood drawn at the time of treatment by venipuncture in acid citrate dextrose (acts as an anticoagulant) tubes 2. Do not chill the blood. 3. Centrifuge the blood using a 'soft' spin (1st centrifugation). 4. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant).

5. Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate (2nd centrifugation).

6. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed.

7. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.

8.Thrombin (dose) was added to activate PRP


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 30, 2019


Arm Intervention/treatment
Active Comparator: Platelet rich plasma
endoscopic injection of PRP
Drug: PLATELET RICH PLASMA
PRP was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
Other Name: PRP

Placebo Comparator: CONTROL GROUP
diluted epinephrine
Drug: diluted epinephrine
diluted epinephrine was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
Other Name: Hemostasis




Primary Outcome Measures :
  1. bleeding [ Time Frame: 3 months ]
    control of peptic ulcer bleeding


Secondary Outcome Measures :
  1. improved iron indices [ Time Frame: 3 months ]
    imroved complete blood count element



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have a peptic ulcer with either actively bleeding or a non-bleeding visible vessel
  • initial hemoglobin concentration of < 10 g/dL

Exclusion Criteria:

  • Patients with non-PUB, coagulopathy, bleeding disorders, anticoagulant therapy, cardiopulmonary compromise, hypertension, ischemic heart disease, arrhythmia, and patients who refused to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733171


Contacts
Contact: Waseem Seleem, MD +201026258004 WASEEMMOHAMED1975@GMAIL.COM
Contact: Amr Hanafy, md +201100061861 dr_amr_hanafy@yahoo.com

Locations
Egypt
Zagazig University Recruiting
Zagazig, Sharkia, Egypt, 44519
Contact: Waseem Seleem, md    +201025264008    waseemmohamed1975@gmail.com   
Contact: Amr Hanafy, md    +201100061861    dr_amr_hanafy@yahoo.com   
Sponsors and Collaborators
Zagazig University
Investigators
Principal Investigator: WASEEM SELEEM, MD zagazig university hospital

Responsible Party: Amr Shaaban Hanafy, Assistant professor of medicine, Zagazig University
ClinicalTrials.gov Identifier: NCT03733171     History of Changes
Other Study ID Numbers: 4940
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amr Shaaban Hanafy, Zagazig University:
platelet rich plasma

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer Hemorrhage
Gastrointestinal Hemorrhage
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents