Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03453749
Status:
WITHDRAWN
Last Update Posted:
2018-12-12
First Post:
2017-12-13
Brief Title:
Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury
Sponsor:
Peter Siesjö
Organization:
Skane University Hospital
Study Overview
Official Title:
Anti-secretory Factor as a Treatment for Adults With Severe Traumatic Head Injury
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
New study in planning
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SATSWEDEN
Brief Summary:
IntroductionBackground Brain swellingbrain edema can occur due to many pathologies of the brain such as infections ischemia and trauma
The edema can be either primarily intra-cellular or extra-cellular The mechanisms by which edema arise are not fully known but it is proposed that inside the damaged brain fluid will pass over the blood-brain barrier of the vessels into the extra-cellular space The accumulation of fluid will lead to an increase in distance between the cell and its closest capillary which may lead to energy failure and intra-cellular edema The extra volume of the fluid leads to increased intracranial pressure which in turn leads to an increase in blood pressure aggravating the edema In addition to the physiological changes that occur the edema will be increased by the immunological response to the tissue damage with release of pro-inflammatory cytokines that give rise to both extra- and intra-cellular edema
Today no treatment has been proven efficient against traumatic brain edema AF - anti-secretory factor is a 41 kDa protein that exists in humans and most animals It was discovered due to its ability to inhibit experimental diarrhea
AF has been proven to have an effect on Mb Menière and glaucoma In animal models AF has been proven efficient in reducing increased intracranial pressure caused by trauma and virus infection in the brain
Salovum an egg yolk powder enriched in AF is registered in the European Union as a medical food
Methods 5 adult patients with severe traumatic brain injury will be included in the trial via next of kin consent
Medical interventions are protocol based The protocol includes first second and third treatment levels
Patients included in the trial will receive two micro-dialysis MD catheters in addition to standard treatment One catheter will be placed in a separate burr hole close to the ICP and LICOX catheter the other MD catheter will be placed in vicinity of the damaged barin tissue
Patients will receive Salovum 6 hours after trial inclusion Patient dosage is 1gkg body weight24 hours divided into 6 doses and administered orally via tubing every 4 hours for 5 consecutive days
Objective Primary end-point is to investigate if Salovum has a beneficiary effect on ICP
Secondary endpoints are to investigate if Salovum has a beneficiary effect on treatment intensity levels TIL brain-oxygenation microdialysis bio-chemistry and cytokine expression in plasma and microdialysate
The edema can be either primarily intra-cellular or extra-cellular The mechanisms by which edema arise are not fully known but it is proposed that inside the damaged brain fluid will pass over the blood-brain barrier of the vessels into the extra-cellular space The accumulation of fluid will lead to an increase in distance between the cell and its closest capillary which may lead to energy failure and intra-cellular edema The extra volume of the fluid leads to increased intracranial pressure which in turn leads to an increase in blood pressure aggravating the edema In addition to the physiological changes that occur the edema will be increased by the immunological response to the tissue damage with release of pro-inflammatory cytokines that give rise to both extra- and intra-cellular edema
Today no treatment has been proven efficient against traumatic brain edema AF - anti-secretory factor is a 41 kDa protein that exists in humans and most animals It was discovered due to its ability to inhibit experimental diarrhea
AF has been proven to have an effect on Mb Menière and glaucoma In animal models AF has been proven efficient in reducing increased intracranial pressure caused by trauma and virus infection in the brain
Salovum an egg yolk powder enriched in AF is registered in the European Union as a medical food
Methods 5 adult patients with severe traumatic brain injury will be included in the trial via next of kin consent
Medical interventions are protocol based The protocol includes first second and third treatment levels
Patients included in the trial will receive two micro-dialysis MD catheters in addition to standard treatment One catheter will be placed in a separate burr hole close to the ICP and LICOX catheter the other MD catheter will be placed in vicinity of the damaged barin tissue
Patients will receive Salovum 6 hours after trial inclusion Patient dosage is 1gkg body weight24 hours divided into 6 doses and administered orally via tubing every 4 hours for 5 consecutive days
Objective Primary end-point is to investigate if Salovum has a beneficiary effect on ICP
Secondary endpoints are to investigate if Salovum has a beneficiary effect on treatment intensity levels TIL brain-oxygenation microdialysis bio-chemistry and cytokine expression in plasma and microdialysate
Detailed Description:
MD will be analysed bedside hourly for patient management and the remaining MD samples will be frozen in -70 C for later analysis of cytokines
An extra blood sample will be drawn twice daily blood will be centrifuged and plasma will be frozen in -70 C for later analysis of cytokines
An extra blood sample will be drawn twice daily blood will be centrifuged and plasma will be frozen in -70 C for later analysis of cytokines
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