Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias (OCEAN)
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| ClinicalTrials.gov Identifier: NCT02384122 |
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Recruitment Status : Unknown
Verified April 2018 by Radboud University Medical Center.
Recruitment status was: Recruiting
First Posted : March 10, 2015
Last Update Posted : April 19, 2018
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The purpose of this study is to determine whether long-acting octreotide is effective in the treatment of patients with refractory anaemia due to angiodysplasias.
The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron infusion requirements in those patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Angiodysplasia Vascular Malformations Gastrointestinal Hemorrhage Anemia | Drug: Octreotide | Phase 2 Phase 3 |
Rationale:
Gastrointestinal angiodysplasias are an important cause of difficult to manage bleeding, especially in older patients. Angiodysplasias are technical challenging to manage endoscopic. Some patients are blood transfusion or iron infusion dependent due to rebleedings despite endoscopic intervention. In clinical practice we face difficulties in these patients as there is no known effective alternative treatment. In small cohort studies octreotide appears to decrease the bleeding episodes in those patients, but the evidence is still to weak to integrate this treatment modality in daily practice.
Objective:
To assess the efficacy of octreotide in decreasing the need for blood transfusions or iron infusion in patients with refractory anaemia due to gastrointestinal bleedings of angiodysplasias despite endoscopic intervention.
Study design:
Multicenter, randomized, open-label intervention study.
Study population:
62 patients, older than 45 years, with refractory anaemia due to bleeding of angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.
Intervention:
Patients will be randomized (1:1) into two groups. The intervention group receives Octreotide 40 mg (Sandostatin LAR) once every four weeks for 48 weeks. The control group receives standard of care. The last follow-up visit is in week 60.
Main study parameters/endpoints:
The primary outcome is the percentual decrease in blood and iron requirements between the year prior to inclusion and the treatment period of one year. The percentual decrease will be compared between the intervention and control arm.
Important secondary outcomes are the percent change in the number of rebleeds from baseline to endpoint and the percentage of adverse events. An intention-to-treat analysis will be performed of the outcomes.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anaemia Due to Angiodysplasias |
| Study Start Date : | September 2015 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | December 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Octreotide
Drug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection
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Drug: Octreotide
Two injections of 20 mg will be given monthly.
Other Names:
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No Intervention: Standard of care
Patients receive standard of care without a placebo.
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- The mean difference in blood and iron requirements. [ Time Frame: Comparing the one year before inclusion and the study period (until week 52) ]
The mean/median difference in blood and iron requirements between the one year prior to inclusion and the treatment period of one year compared between the intervention and control arm.
All blood transfusions that are given with another indication than gastrointestinal blood loss are registered, but excluded for analysis for the primary outcome.
- Percentage of hemoglobin increase from baseline until end of treatment visit. [ Time Frame: From inclusion in the study until end of treatment visit (week 48). ]Change in haemoglobin level comparing the octreotide the control arm, as assessed as slope through all haemoglobin measurements taken at study visits during the treatment phase.
- Number of patients requiring red blood cell transfusions [ Time Frame: From inclusion in the study until end of treatment (week 52). ]Comparing the octreotide with the control arm.
- The mean difference in hemoglobin level [ Time Frame: From inclusion in the study until end of treatment visit (week 48). ]Comparing the octreotide with the control arm.
- Change in number and severity of bleeding episodes [ Time Frame: From inclusion in the study until end of treatment visit (week 52). ]Comparing the octreotide with the control arm.
- Number of patients free of rebleeding [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]Comparing the octreotide with the control arm.
- The number and type of adverse events [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]Comparing the octreotide with the control arm.
- Difference in number of hospitalizations, ICU admissions and duration of hospitalization [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]Comparing the octreotide with the control arm.
- Difference in need for rescue therapy [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]Comparing the octreotide with the control arm for use of argon plasma coagulation, coiling or surgery.
- Mortality and cause of death [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]Comparing the octreotide with the control arm.
- Difference in quality of life [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]Quality of Life as measured by SF36 and PSQ-An questionnaire. Comparing the octreotide with the control arm.
- Number of patients requiring other transfusions or medication to correct coagulation [ Time Frame: From baseline until end of treatment (week 52). ]Comparing the octreotide with the control arm.
- Percentual reduction in oral iron requirement [ Time Frame: From baseline until end of treatment (week 52). ]Comparing the octreotide with the control arm.
- The change in level of serum ferritin [ Time Frame: From baseline until end of treatment visit (week 48). ]Comparing the octreotide with the control arm.
- The percentual decrease in blood and iron infusions. [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]The percentual decrease in blood and iron infusions between the intervention arm compared to the control group.
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- proven angiodysplasias, without any other possible source of gastrointestinal bleeding.
- transfusion dependency: at least 4 blood transfusions or iron infusions in the year before inclusion, despite an attempt to supplement iron orally
- failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures
- providing informed consent
- older than 45 years
Exclusion Criteria:
- age < 45 years
- liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
- previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
- current thalidomide treatment which is effective (no transfusion dependency)
- severe diseases with life expectancy < 1 year
- patients with left ventricular assist devices (LVAD's)
- Rendu-Osler-Weber
- pregnancy or nursing women
- uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
- hereditary hemorrhagic diseases or haematological disorders with active treatment
- patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
- symptomatic cholecystolithiasis
- non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
- systemic cancer currently undergoing chemotherapy or radiation therapy
- refusal to enter the study
- no understanding of Dutch or English
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): NCT02384122
| Contact: Karina Grooteman, MD | 003124 - 8187314 | karina.grooteman@radboudumc.nl | |
| Contact: Erwin van Geenen, MD, PhD | 003124 - 8187313 | erwin.vangeenen@radboudumc.nl |
| Netherlands | |
| Gelre Hospitals | Recruiting |
| Apeldoorn, Gelderland, Netherlands, 7334 DZ | |
| Contact: H. Braat, MD, PhD 055 581 8181 h.braat@gelre.nl | |
| Radboudumc | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6525 GA | |
| Contact: K.V. Grooteman, MD 0031 24 8187314 karina.grooteman@radboudumc.nl | |
| Jeroen Bosch Hospital | Not yet recruiting |
| 's-Hertogenbosch, Noord-Brabant, Netherlands, 5200 ME | |
| Contact: Bob Scheffer, MD, PhD 003173-5533051 b.scheffer@jbz.nl | |
| Catharina hospital | Recruiting |
| Eindhoven, Noord-Brabant, Netherlands, 5623 EJ | |
| Contact: Lennard Gilissen, MD, PhD 003140-239 9111 lennard.gilissen@catharinaziekenhuis.nl | |
| St. Elisabeth Hospital | Recruiting |
| Tilburg, Noord-Brabant, Netherlands, 5022 GC | |
| Contact: Robert Laheij, MD, PhD 013 539 1313 r.laheij@elisabeth.nl | |
| VU Medical Center | Not yet recruiting |
| Amsterdam, Noord-Holland, Netherlands, 1007 MB | |
| Contact: Maarten Jacobs, MD, PhD 003120-44 444 44 majm.jacobs@vumc.nl | |
| St Antonius Hospital | Not yet recruiting |
| Nieuwegein, Utrecht, Netherlands, 3430 EM | |
| Contact: Jacco Tenthof - van Noorden, MD, PhD 003188 - 3203000 j.tenthof@antoniusziekenhuis.nl | |
| Reinier de Graaf Groep | Recruiting |
| Delft, Zuid-Holland, Netherlands | |
| Contact: Dr. B. Veldt, MD, PhD | |
| Bernhoven | Not yet recruiting |
| Uden, Netherlands | |
| Contact: Dr. N. Talstra, MD | |
| Principal Investigator: | Joost Drenth, MD. PhD | Radboud University Medical Center |
Study Data/Documents: Study Protocol
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radboud University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02384122 |
| Other Study ID Numbers: |
NLOCEAN.50514.091.14 |
| First Posted: | March 10, 2015 Key Record Dates |
| Last Update Posted: | April 19, 2018 |
| Last Verified: | April 2018 |
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Angiodysplasias Sandostatin LAR Gastrointestinal Somatostatin Octreotide |
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Octreotide Gastrointestinal Hemorrhage Vascular Malformations Angiodysplasia Anemia Hemorrhage Hematologic Diseases Pathologic Processes Congenital Abnormalities |
Gastrointestinal Diseases Digestive System Diseases Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |