St George's Hospital UK Study of the use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN02543733

Enrollment

Registered

2003-09-12

Start date

2002-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Acetabular reconstruction Surgery Other and specified injuries of hip and thigh

Interventions

Use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18?60 yr old 2. major pelvic?acetabular fracture caused by trauma 3. scheduled for semi-elective ?large? reconstruction surgery with the potential of blood loss exceeding 50% of circulating blood volume

Exclusion criteria

Exclusion criteria: 1. history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis) 2. severe head injuries or an abnormal CT scan of the head due to head injuries 3. base deficit of greater than 15 mEq litre?1 or severe acidosis (pH<7.0.) before surgery 4. body weight exceeding 135 kg 5. known or suspected allergy to any drug that may be administered during the course of the study 6. cardiac arrest after trauma and before surgery at St George's Hospital 7. known congenital bleeding disorders 8. known pregnancy or positive pregnancy test at enrolment 9. previous participation in this study 10. previous receipt of rFVIIa within 48 h of screening 11. currently participating or having participated in another investigational drug study within the last 30 days

Design outcomes

Primary

Measure	Time frame
Total volume of perioperative blood loss	—

Secondary

Measure	Time frame
1. perioperative transfusion requirement (total volume of allogeneic blood components and salvaged RBC, total number of units of allogeneic blood components) 2. number of patients transfused with allogeneic blood components 3. total volume of crystalloid (Hartmann's solution, dextrose saline, normal saline) and colloid (succinylated gelatin) fluids infused 4. total operating time 5. time taken after entry to intensive care unit (ICU) or recovery unit to reach normal body temperature (36.3?37.1°C) and acid?base status (blood pH 7.35?7.45 with standard base excess ?2 to +2) 6. time spent in ICU after surgery 7. days of hospitalization 8. number of times a patient was returned to the operating theatre	—

Measure

Time frame

1. perioperative transfusion requirement (total volume of allogeneic blood components and salvaged RBC, total number of units of allogeneic blood components) 2. number of patients transfused with allogeneic blood components 3. total volume of crystalloid (Hartmann's solution, dextrose saline, normal saline) and colloid (succinylated gelatin) fluids infused 4. total operating time 5. time taken after entry to intensive care unit (ICU) or recovery unit to reach normal body temperature (36.3?37.1°C) and acid?base status (blood pH 7.35?7.45 with standard base excess ?2 to +2) 6. time spent in ICU after surgery 7. days of hospitalization 8. number of times a patient was returned to the operating theatre

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026