Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214845
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-02
Brief Title:
Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Early-goal Directed Automated Red Blood Cell Exchange for Acute Chest Syndrome in Sickle Cell Disease a Multicentre Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCAD
Brief Summary:
Sickle cell disease SCD is characterized by recurrent vaso-occlusive pain crisis VOC which may evolve to acute chest syndrome ACS the most common cause of death among adult patients with SCD Currently there is no etiologic treatment to abort ACS Therefore management of ACS mostly involve a symptomatic approach including in routine and as per recommendations hydration analgesics supplemental oxygen and transfusion
The polymerisation of sickle haemoglobin HbS is one major feature in the pathogenesis of vaso-occlusion Current guidelines recommend red blood cell exchange transfusion REX in patients with severe ACS in order to improve oxygenation and reduce HbS concentration to blunt sickling REX is often preferred over simple transfusion in this setting because it rapidly reduces HbS without raising final haematocrit There are currently two methods for REX manual with sequential phlebotomies and transfusions or automated erythrocytapheresis The former allows a sober use of red blood cell packs while the latter achieves haematological targets HbS and haematocrit quickly and more consistently but requires a special equipment and trained staff As a result of inflammation and intravascular hemolysis the plasma of patients with ACS may also contain several components that promote vaso-occlusion lung injury and organ failure including cytokines eg IL-6 free haemoglobin and free haem Conversely it is depleted in haptoglobin and hemopexin which normally bind to and clear cell-free haemoglobin The addition of therapeutic plasma exchange to erythrocytapheresis during automated REX may therefore have a dual beneficial effect in patients with overt intravascular hemolysis i deplete the inflammatory mediators and products of hemolysis ii replete haptoglobin and hemopexin REX modalities automated vs manual have not been tested during ACS
The hypothesis is that early-goal directed automated REX may accelerate the resolution of severe ACS as compared to manual REX
The polymerisation of sickle haemoglobin HbS is one major feature in the pathogenesis of vaso-occlusion Current guidelines recommend red blood cell exchange transfusion REX in patients with severe ACS in order to improve oxygenation and reduce HbS concentration to blunt sickling REX is often preferred over simple transfusion in this setting because it rapidly reduces HbS without raising final haematocrit There are currently two methods for REX manual with sequential phlebotomies and transfusions or automated erythrocytapheresis The former allows a sober use of red blood cell packs while the latter achieves haematological targets HbS and haematocrit quickly and more consistently but requires a special equipment and trained staff As a result of inflammation and intravascular hemolysis the plasma of patients with ACS may also contain several components that promote vaso-occlusion lung injury and organ failure including cytokines eg IL-6 free haemoglobin and free haem Conversely it is depleted in haptoglobin and hemopexin which normally bind to and clear cell-free haemoglobin The addition of therapeutic plasma exchange to erythrocytapheresis during automated REX may therefore have a dual beneficial effect in patients with overt intravascular hemolysis i deplete the inflammatory mediators and products of hemolysis ii replete haptoglobin and hemopexin REX modalities automated vs manual have not been tested during ACS
The hypothesis is that early-goal directed automated REX may accelerate the resolution of severe ACS as compared to manual REX
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None