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Supplemental Appendix 1. Clinical Research File
Preoperative versus postoperativeinitiation of thromboprophylaxis. Effect on coagulation, fibrinolysis, and bleeding in patients undergoing cemented THA.
Patient ID:
Number of randomization:
Signature:
Aims of the study:
To see if there are any clinically significant differences in (1)blood loss and (2)bleeding events and blood transfusions comparing preoperative with postoperative initiation of thromboprophylaxis.
Hospitalization Day1:
1.Date(dd/mm/year):______
2. Gender (F/M):Female/ male
3. Height(cm):______cm
4. Weight(kg):______kg
5. Body mass index (BMI = weight/heightx height): ______kg/m 2
Inclusion: YesNo
Primary coxarthrosis
50 years or older
Cemented Exeter THA
Signed written consent and patient information
Exclusion: YesNo
Bleeding disorder or bleeding tendency
Coagulation disorder
History of venous thromboembolism, deep venous thrombosis, or pulmonary embolism
NSAIDSwitha half-life of 18hours or moreduring last week
Active malignancy
Myocardial infarction last 3 months
Stroke last 3 months
Major trauma last 3 months
Chronic lung disease
Allergy to low molecular-weight heparin
Alcohol or drug abuse
Liverdisease
Renal failure
Concomitant disease:
Medication:
Laboratory testsDay 1:
Hemoglobin (g/dL): _____
Hematocrit(%):_____
Thrombocytes:_____
C reactive protein (mg/dL):_____
Creatinine:_____
Aspartate amino transferase (ASAT)
Alanine amino transferase (ALAT): _____
Preoperative injection:
Date (dd/mm/year):______Time (hours:minutes):______
Day of surgery -Day 0:
Date (dd/mm/year):______
Surgery:
Operation start:______
Operationend:______
Operation time(minutes):______
Perioperative bleeding (mL):______
Fluids during surgery (mL):
Voluven (mL):______
Glucose (mL):______
Ringer (mL):______
Other (mL):_____
Units of packed red blood cells:______
1. PostoperativeFragmin injection(hours/mm):______
.
Hemoglobin (g/dL): ______
Hematocrit (%):______
Until 1 postoperative injection
Fluids in drain (mL):______
Fluids transfused (mL):
Glucose:_____
Voluven:_____
Ringer:_____
Other:_____
Units of packed red blood cells:______
Bleeding events or other adverse events:YesNo
(definitions page10) If yes,complete report adverse event.
Day after surgery- Day 1:
Date (dd/mm/year):_____
Drain removed – Time (hours:minutes): _____
Hemoglobin (g/dL):_____
Hematocrit: (%)_____
Fluids in drain (mL) _____
Fluids transfused(mL):
Glucose:_____
Voluven:_____
Ringer:_____
Other: _____
Units of packed red blood cells:_____
Total perioperativeand postoperative bleeding (mL)_____
Bleeding events or other adverse events: YesNo
(definitions page10). If yes,complete report adverse event.
Postoperative Days – Days 2-5:
Date (dd/mm/year):_____
Hemoglobin (g/dL):_____
Hematocrit: (%)_____
C- reactive protein (CRP):_____
Fluids transfused (mL)
Glucose:_____
Voluven:_____
Ringer:_____
Other:_____
Unitspacked red blood cells _____
Bleeding events or other adverse events: YesNo
(definitions page10). If yes,complete report adverse event.
Postoperative Day6:
Date (dd/mm/year):_____
Hemoglobin (g/dL):_____
Hematocrit: (%)_____
C reactive protein:_____
Fluids transfused (mL)
Glucose:_____
Voluven:_____
Ringer:_____
Other:_____
Units packed red blood cells _____
Bleeding events or other adverse events: YesNo
(definitions page10). If yes,complete report adverse event.
Last day of hospitalization:
Date (dd/mm/year):_____
Number of days including day of surgery:_____
Medication during hospitalization:
Fluids transfused during hospitalization- total (mL):
Voluven: ______
Ringer: ______
Glucose: ______
Other:______
Units packed red blood cells transfused during hospitalization- total______
Adverse events during hospitalization
(definitions on page10) Yes No
If yes, what kind of adverse event:
Bleeding events:Yes No
Thromboembolic events:Yes No
Other complications: Yes No
If Yes, complete report adverse event.
Followup 6 months:
Thrombolic events:
Pulmonary embolism (PE)
Deep venous thrombosis (DVT)
Transitory ischemic attack (TIA)
Thrombosis/embolus ofcentral nervous system (CNS)and retinal vessels
Ischemic heart disease
Postthrombotic syndrome– pain, tenderness, and swollen leg
Postoperative confusion
Other possible thromboembolic events
Bleeding events:
Hematoma at injection siteor hip
Prolonged secretion
Excessive bleeding leading to reoperation
Central nervous system bleeding
Gastrointestinal bleeding
Hematuria
Other bleeding events
Other complications:
Allergic reactions
Peripheral nerve injury
Pneumonia
Dislocation of hip
Superficial wound infection
Deep infection
Reoperation
Readmission to hospital
Other disease diagnosed after surgery and until followup
Definitions:
Adjudicated clinical bleeding events
Serious / Moderate / MildBleeding intocentral nervous system / Spontaneous skin hematoma≥25 cm / Any other bleeding event
Retroperitoneal bleeding / Wound hematoma≥ 100cm
Fatal bleeding / Spontaneous nose bleed≥ 5 minutes
Bleeding causing treatment cessation / Spontaneous macroscopic hematuria
Bleeding causing reoperation / Spontaneous rectal bleeding more than spot on toilet paper
Gingival bleeding ≥ 5 minutes
REPORT - ADVERSE EVENTS:
Patient number:______Randomization number:______
Type of event: ______
Date event:______
Treatment event:______
Result of treatment:______
New followup/date:______
______
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