Platelet Rich Plasma in Bleeding Peptic Ulcer
Keywords
Abstract
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
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 11/04/2018 |
| Estimated Enrollment Submitted: | 11/04/2018 |
| First Posted: | 11/06/2018 |
| Last Update Submitted: | 06/04/2019 |
| Last Update Posted: | 06/06/2019 |
| Actual Study Start Date: | 09/19/2018 |
| Estimated Primary Completion Date: | 05/31/2019 |
| Estimated Study Completion Date: | 06/29/2019 |
Condition or disease
Intervention/treatment
Drug: Platelet rich plasma
Drug: CONTROL GROUP
Device: CONTROL GROUP
Phase
Arm Groups
| 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 |
| Placebo Comparator: CONTROL GROUP diluted epinephrine | Drug: CONTROL GROUP 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. bleeding [3 months]
Secondary Outcome Measures
1. improved iron indices [3 months]
