Gastrointestinal bleeding (or GI bleeding) is typically a symptom of a digestive tract disorder. It can also occur as an adverse effect of an invasive endoscopic procedure. To control a GI bleed, clipping devices and hemostatic devices like COOK Medical Hemospray® can be used. Dr. Shou-jiang Tang, Director of Endoscopic Research and Advanced Endoscopy at the University of Mississippi Medical Center, discussed at the 2023 PSDE Endoscopycon how Hemospray works and its use in nonvariceal and variceal GI bleeding.
What is Hemospray?
Hemospray is an inert powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the site of the bleed. It contains no human or animal proteins or botanicals and has no known allergens.
How does it control gastrointestinal bleeding? When the powder is sprayed over the bleeding site, it absorbs water from the blood. Then, it acts cohesively and adhesively and forms a mechanical barrier.
Effects on coagulation and clot formation
Studies show that hemostatic powder has concentrated clotting factors, which allow it to form a mechanical plug that protects the injured blood vessel. In an ex vivo study in 2015, Hemospray is found to reduce the following:
- Recalcification time of whole blood
- Clotting time of whole blood
- Plasma prothrombin time
Scanning electron microscope (SEM) images of in vivo clots show the same as the powder rapidly interacts with whole blood, forming one confluent mass over the bleeding site.
“Fire extinguishing powder”
Due to its influence on coagulation and clot formation, Hemospray can be compared to a fire extinguishing powder. In an endoscopic procedure, the user can just spray the powder over the bleeding site to be able to declare “fire out” immediately.
A randomized study about the early application in esophagogastric variceal bleeding showed that the clinical efficacy of using the powder is higher, compared to standard care (Gut, 2018). Two groups of 43 patients each were observed for the study. In the first group, patients received standard care, while in the other, patients received Hemospray treatment. Clinical hemostasis was achieved at 73% with standard care and 88% with Hemospray. There was 100% hemostasis achieved at 12 hours after Hemospray and 90% after standard therapy. Treatment failure at 5 days was 12% after Hemospray, and 38% after standard therapy. Death occurrence is also less, only 7%, and 30% under standard therapy. Contraindications include patients who have GI fistulas, are suspected of having gastrointestinal perforation, or are at high risk of perforation during endoscopic treatment, according to COOK Medical.
Hemospray as a first-line monotherapy
In the study of Tang et al., the authors proposed that in patients with diffuse esophageal ulcerations with clinically significant bleeding, Hemospray should be considered as the first-line monotherapy. It can help achieve hemostasis and potentially reduce the need for repeat endoscopy. The rationale for the proposal is as follows:
- Conventional hemostatic therapy such as thermal coagulation and clipping is difficult to apply in diffusely bleeding esophageal ulcerations and is associated with a small risk of treatment related perforation.
- No large vessel is generally encountered in diffuse esophageal ulcerations. Once Hemospray achieves hemostasis, it provides a cyto-protective barrier to the diffusely ulcerated mucosa against acid reflux, allowing the new tissue to grow more efficiently during ulcer healing.
A 2018 study using the hemostatic powder demonstrated overall primary hemostasis of 90% and a rebleeding risk of about 20%. Barkun et al. described that with a patient with upper nonvariceal GI bleeding and low risk of delayed bleed, using Hemospray as initial monotherapy can be cost effective.
Gastrointestinal bleeding after endoscopy
In 2015, a separate study published a single center institution’s experience in using Hemospray in lower GI bleeding. Sixty patients received 67 treatments with the hemostatic powder. The patients had immediate hemostasis of 99% and experienced no serious adverse effects. The powder also was generally not visible and was dissolved or flushed out within two days. The powder will not interfere with additional therapy or a biopsy if needed after one to two days.
A paper published in the Gastrointestinal Endoscopy journal, Dr. Pittayanon et al. found that conventional endoscopic hemostatic methods are not effective in cancer-related bleeding, about 31%-93%. Bleeding risk is very high. In 99 patients included in the cohort, immediate hemostasis was achieved at 98%, with recurrent bleeding in 15%. Gastrointestinal bleeding could be delayed within three to 30 days. Without the powder, the recurrent bleeding rate was 38%.
Hemospray in practice
If gastrointestinal bleeding occurs or diffuse bleeding is suspected during initial endoscopy, the hemostatic powder can be used to stop the bleeding. After one to two days, the site can be checked again to see if there is a tumor. If a tumor is found, patient can be called in to discuss options such as chemotherapy, radiation therapy, and so on. Otherwise, further endoscopic therapy or biopsy may be needed. If bleeding occurs and cannot be stopped with standard endoscopic therapy, the powder can be used as needed.
User-friendly hemostat device
Mastery of a medical device takes some practice before a seamless user experience is achieved. Hemospray, however, is non-contact, non-thermal, safe, and easy to use. The user, whether an endoscopist, technician, or nurse assistant can use it easily. Endoscopists who are still in training or uncomfortable using other devices can use the hemostatic powder instead. To stop the bleed, they spray it over the affected site, bleeding stops, and wait until the patient is transferred for surgery if needed. There is no need to worry about applying the right pressure to achieve coagulation or whether perforation will press too deep. Literature is also available for the user when in need of help. You may contact a Product Applications Specialist for a demonstration of the product.
Using Hemospray to control nonvariceal gastrointestinal bleeding is 97%-98% effective. It can be considered as a first-line monotherapy in diffusely bleeding conditions such as tumor-related bleeding, esophagitis, ulcerations, etc. Also, it can lower risk of recurrent bleeding and is cost effective.
References:
- Holster IL, van Beusekom HM, Kuipers EJ, et al. Endoscopy 2015;47(7):638–45.
- Early application of haemostatic powder added to standard management for oesophagogastric variceal bleeding: a randomized trial. Gut 2018;0:1–10.
- Ibrahim et. al. Gut 2018;0:1–10.
- Tang, et. al. VideoGIE 2019;4(3):142-144. doi: 10.1016/j.vgie.2018.12.010.
- Barkun AN, et. al. J Clin Gastroenterol. 2018;52(1):36-44.
- Annals of Gastroenterology (2020) 33, 145-154.
- Chen YI, Barkun A, Nolan S. Endoscopy 2015;47(2):167–71.
- Hookey L, Barkun A, et al. GIE 2019;89:865.
- Pittayanon R, Rerknimitr R, Barkun A. GIE. 2018 ;87(4):994-1002.
- Mullady, Wang, Waschke. Gastroenterology 2020 159:1120–1128.
- Chen, Barkun A. Gastrointest Endosc 2020;91:321-8.
- Baracat et. al. Surg Endosc 2020;34:317–324.
- Mullady, Wang, Waschke. Gastroenterology 2020;159:1120–1128.
