Trial Outcomes & Findings for A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment (NCT NCT03276975)
NCT ID: NCT03276975
Last Updated: 2021-06-18
Results Overview
Absolute change in median HIT-6 score from pre-procedural baseline to 1 month post procedure for each group. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.
COMPLETED
PHASE2
15 participants
Baseline, 1 month
2021-06-18
Participant Flow
Participant milestones
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
Crossover At 2 Months
|
0
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Baseline characteristics by cohort
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthAbsolute change in median HIT-6 score from pre-procedural baseline to 1 month post procedure for each group. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline
|
-12 score on a scale
Interval -16.0 to -7.0
|
-7 score on a scale
Interval -13.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 monthsPopulation: All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
Absolute change in median HIT-6 score from pre-procedural baseline to 2 weeks and 4 months post procedure for each group. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in Median HIT-6 Score From Baseline
2 weeks
|
-5.5 units on a scale
Interval -10.0 to 0.5
|
-7 units on a scale
Interval -17.0 to -3.0
|
|
Change in Median HIT-6 Score From Baseline
4 months
|
-4.5 units on a scale
Interval -16.5 to -1.5
|
-12 units on a scale
Interval -24.0 to -7.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 1 month, 4 monthsPopulation: All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
The MIDAS questionnaire assesses headache-related disability. Patients answer five questions, scoring the number of days, in the past 3 months, where their activity was limited due to headache. A higher score indicates greater headache-related disability. This tool has been shown to be internally consistent, highly reliable, valid, and correlates with physicians' clinical judgment. MIDAS Scale Range: 0 - 270
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Reduction in Median Migraine Disability Assessment (MIDAS) Score From Baseline
2 weeks
|
-25 units on a scale
Interval -55.0 to 6.0
|
16 units on a scale
Interval -35.0 to 100.0
|
|
Reduction in Median Migraine Disability Assessment (MIDAS) Score From Baseline
1 month
|
-62.5 units on a scale
Interval -117.0 to -37.0
|
-40 units on a scale
Interval -86.0 to -3.0
|
|
Reduction in Median Migraine Disability Assessment (MIDAS) Score From Baseline
4 months
|
-87 units on a scale
Interval -134.5 to -69.5
|
-53 units on a scale
Interval -210.0 to -22.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 1 month, 4 monthsPopulation: All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain"). It has been found to be a valid measure of pain intensity with minimum clinically important difference noted to be a change of 2 points. The investigators will use NRS averaged over the past 24 hours for all time points in this trial. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus statement indicates that an NRS reduction of 30% (or 2 points) is associated with a meaningful or moderately important improvement in pain. Further, IMMPACT also indicates that an NRS reduction of 50% (or 4 points) is associated with a substantial improvement in pain. The investigators will follow their consensus recommendations and explicitly report these two categories of pain relief.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in Median NRS Score From Baseline
2 weeks
|
-0.5 units on a scale
Interval -1.5 to 1.0
|
-1 units on a scale
Interval -3.0 to 0.0
|
|
Change in Median NRS Score From Baseline
1 month
|
-2.5 units on a scale
Interval -4.5 to -1.0
|
0 units on a scale
Interval -3.0 to 3.0
|
|
Change in Median NRS Score From Baseline
4 months
|
-1.5 units on a scale
Interval -5.0 to -0.5
|
-2 units on a scale
Interval -3.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 1 month, 4 monthsPopulation: All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
The EQ-5D is a standardized measure of health status that provides a simple, generic measure of health for clinical appraisal. It is well-validated for health status measurement and for quality-of-life in headache. Scores on the EQ-5D were calculated using the United States 3L, time trade off (TTO) valuation technique. Scores range from 0 to 1, with 1 indicating perfect health.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline
2 weeks
|
0.1 units on a scale
Interval 0.0 to 0.2
|
0.1 units on a scale
Interval -0.1 to 0.3
|
|
Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline
1 month
|
0 units on a scale
Interval 0.0 to 0.4
|
0.1 units on a scale
Interval 0.0 to 0.4
|
|
Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline
4 months
|
0 units on a scale
Interval -0.1 to 0.1
|
0.2 units on a scale
Interval 0.1 to 0.4
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 1 month, 4 monthsPopulation: Patients were only analyzed with respect to WPAI if they were currently employed at the time of the outcome measure acquisition (for each time point). Thus, there were fewer patients for whom data was recorded than were enrolled in each arm (number analyzed). All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
The WPAI is a validated instrument with good test-retest reliability used extensively in health research that quantifies impairment in daily activities and work productivity. Scores on the WPAI range from 0 - 100% with higher percentages indicating greater impact on work productivity and more severe activity impairment.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in Median WPAI (Work Productivity and Activity Impairment) Score From Baseline
2 weeks
|
1.3 units on a scale
Interval -16.9 to 13.5
|
-0.3 units on a scale
Interval -8.8 to 3.6
|
|
Change in Median WPAI (Work Productivity and Activity Impairment) Score From Baseline
1 month
|
-13.8 units on a scale
Interval -51.0 to 5.0
|
-2.3 units on a scale
Interval -20.8 to 20.0
|
|
Change in Median WPAI (Work Productivity and Activity Impairment) Score From Baseline
4 months
|
-9 units on a scale
Interval -29.0 to 13.7
|
-28.5 units on a scale
Interval -47.0 to -10.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 1 month, 4 monthsPopulation: All patients at the 4 month time point in the Simulated Patching Procedure Arm/Group had crossed over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue Arm/Group
PGIC is a validated 7-point Likert-type scale assessing a patient's overall impression of improvement after intervention. Scores range from 1 - 7 (1: no change or worsening of condition; 2: almost the same, hardly any change at all; 3: a little better, but no noticeable change; 4: somewhat better, but the change has not made any real difference; 5: moderately better, and a slight but noticeable change; 6: better and a definite improvement that has made a real and worthwhile difference; 7: a great deal better, and a considerable improvement that has made all the difference) with higher scores indicating greater improvement.
Outcome measures
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=8 Participants
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 Participants
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Change in PGIC (Patient Global Impression of Change) Score From Baseline
2 weeks
|
3.5 score on a scale
Interval 3.0 to 4.5
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Change in PGIC (Patient Global Impression of Change) Score From Baseline
1 month
|
4 score on a scale
Interval 3.0 to 5.5
|
3 score on a scale
Interval 1.0 to 5.0
|
|
Change in PGIC (Patient Global Impression of Change) Score From Baseline
4 months
|
4.5 score on a scale
Interval 3.5 to 6.0
|
6 score on a scale
Interval 2.0 to 6.0
|
Adverse Events
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
Simulated Patching Procedure
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue
n=15 participants at risk
CT-fluoroscopic guided epidural patching of the CSF leak or CSF to venous fistula with autologous blood and fibrin glue.
|
Simulated Patching Procedure
n=7 participants at risk
A simulated procedure in which CT fluoroscopy is used to place needles but instead of injection of blood and fibrin glue patching material, an equivalent volume of preservative free sterile saline is injected.
|
|---|---|---|
|
Vascular disorders
Asymptomatic self-limited hypertension
|
0.00%
0/15 • Adverse event data were collected immediately after the initial procedure, immediately after any crossover procedures (performed at the 2-month time point), and also at 1 week after any procedure (initial or crossover).
All 7 participants in the Simulated Patching Procedure arm chose to cross over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue arm at the 2-month time point. Therefore, a total of 15 participants received the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue intervention.
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected immediately after the initial procedure, immediately after any crossover procedures (performed at the 2-month time point), and also at 1 week after any procedure (initial or crossover).
All 7 participants in the Simulated Patching Procedure arm chose to cross over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue arm at the 2-month time point. Therefore, a total of 15 participants received the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue intervention.
|
|
Nervous system disorders
Rebound Intracranial Hypertension
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected immediately after the initial procedure, immediately after any crossover procedures (performed at the 2-month time point), and also at 1 week after any procedure (initial or crossover).
All 7 participants in the Simulated Patching Procedure arm chose to cross over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue arm at the 2-month time point. Therefore, a total of 15 participants received the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue intervention.
|
0.00%
0/7 • Adverse event data were collected immediately after the initial procedure, immediately after any crossover procedures (performed at the 2-month time point), and also at 1 week after any procedure (initial or crossover).
All 7 participants in the Simulated Patching Procedure arm chose to cross over to the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue arm at the 2-month time point. Therefore, a total of 15 participants received the Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place