Clinical Trial: Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Ang

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.

Detailed Summary:

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 para
Sponsor: Radboud University

Current Primary Outcome: The mean difference in blood and iron requirements. [ Time Frame: Comparing the one year before inclusion and the study period (until week 52) ]

Original Primary Outcome: Change in units of blood and iron infusion [ Time Frame: From a half year before inclusion in the study until end of treatment visit (week 48) ]

Current Secondary 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.

Original Secondary Outcome:

• Haemoglobin change [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
  Change in haemoglobin level comparing the octreotide the placebo 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 visit (week 48) ]
  Comparing the octreotide with the placebo 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 placebo arm.
• Change in number and severity of bleeding episodes [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
  Comparing the octreotide with the placebo arm.
• Number of patients free of rebleeding [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
  Comparing the octreotide with the placebo 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 placebo arm.
• Difference in number of hospitalizations, ICU admissions and duration of hospitalization [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
  Comparing the octreotide with the placebo arm.
• Difference in need for rescue therapy [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
  Comparing the octreotide with the placebo 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 placebo 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 placebo arm.

Information By: Radboud University

Dates:
Date Received: March 4, 2015
Date Started: September 2015
Date Completion: December 2018
Last Updated: October 17, 2016
Last Verified: October 2016