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Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias (OCEAN)

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ClinicalTrials.gov Identifier: NCT02384122
Recruitment Status : Unknown
Verified April 2018 by Radboud University.
Recruitment status was:  Recruiting
First Posted : March 10, 2015
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
St. Antonius Hospital
Jeroen Bosch Ziekenhuis
VU University Medical Center
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Gelre Hospitals
Reinier de Graaf Groep
Bernhoven Hospital
Information provided by (Responsible Party):
Radboud University

Brief Summary:

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

Detailed Description:

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.

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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
Active Comparator: Octreotide
Drug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection
Drug: Octreotide
Two injections of 20 mg will be given monthly.
Other Names:
  • Sandostatin LAR
  • RVG 18236
  • ATC H01CB02

No Intervention: Standard of care
Patients receive standard of care without a placebo.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Percentual reduction in oral iron requirement [ Time Frame: From baseline until end of treatment (week 52). ]
    Comparing the octreotide with the control arm.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02384122


Contacts
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Contact: Karina Grooteman, MD 003124 - 8187314 karina.grooteman@radboudumc.nl
Contact: Erwin van Geenen, MD, PhD 003124 - 8187313 erwin.vangeenen@radboudumc.nl

Locations
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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         
Sponsors and Collaborators
Radboud University
St. Antonius Hospital
Jeroen Bosch Ziekenhuis
VU University Medical Center
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Gelre Hospitals
Reinier de Graaf Groep
Bernhoven Hospital
Investigators
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Principal Investigator: Joost Drenth, MD. PhD Radboud University
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 27619827

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
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
Keywords provided by Radboud University:
Angiodysplasias
Sandostatin LAR
Gastrointestinal
Somatostatin
Octreotide
Additional relevant MeSH terms:
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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