Early data of the REVERSE-AD trial: 

N=90, 184 sites, 35 countries
Study design: prospective cohort study;
Disclosures: funded by Boehringer Ingelhelm

Inclusion Criteria: 
- People over the age of 18
- Group A: "Overt, uncontrollable or life-threatening bleeding that was judged by the treating clinician to require a reversal agent" (n=51; 18 ICH, 20 GIB, 9 trauma, 11 other)
- Group B: "Those who required surgery or other invasive procedures that could not be delayed for at least 8 hours an for which normal hemostasis was required" (n=39; Bone fractures 8 Acute cholecystitis 5 Acute renal insufficiency, catheter placement 4 Acute appendicitis 3 Joint/wound infection 3 Abscess (suprapubic, scrotal) 2 .... no neurosurgical procedures)

Primary endpoint: 
- Maximum % reversal of dabigatran as determined by dilute thrombin time or ecarin clotting time measurements

Secondary endpoints: 
- proportion of patients with complete normalization of dilute thrombin time or ecarin clotting time in first 4 hours
- Reduction in concentration of unbound dabigatran in the blood.
- Group A: Severity of bleeding (by scales - ISTH, GUSTO, modified rankin)
- Group B: h"hemostasis during the intervention was classified by the physician as normal, or as mildly, moderately, or severely abnormal"

Results: 

All of the figures basically look like this, where the lab values immediately normalize after administration of the sample 

Clinical results? 

Group A
- Of the 18 people with ICH, time to cessation of bleeding could not be ascertained in 5. Overall, the time to cessation of bleeding could not be ascertained in 13 of 51.
- Of the remaining 33, "the median investigator reported time to the cessation of bleeding was 11.4 hours"

Group B
- "normal intraoperative hemostasis was reported in 33 of 36"

Thrombotic Events:
- 5 out of 90 people
- DVT x 3, PE x2, stroke x1, NSTEMI x1

Interesting sidepoint for neurosurgeons
- "the proportion of patients with intracranial bleeding was higher among the 11 patients who had normal results on the clotting tests at baseline than among the 40 who had elevated results at baseline"
- So basically, the people who were LESS anticoagulated had more head bleeds.....

Comments: 
- Clinical endpoints are terrible - what the heck does "the median investigator reported time to the cessation of bleeding was 11.4 hours" even mean? Who is making this call? And by what metric? Is that by CT? Exam? Only 1/3 of the cases were cranial -- it was a potpourri of etiologies. Also, if the reversal happened immediately, why did it take 11 hours to stop bleeding? Is this just people getting a follow up CT scan 6 or 12 or 24 hours afterwards and seeing stability?
- No neurosurgical cases in the B group.
- Non-randomized, non-blinded, no control group